Diet ModificationNCT03878667
Effects of Calcium Supplementation on Women in the Curves for Women Program
A study testing Curves Calcium and Calcium Carbonate in people with Diet Modification, run by Texas A&M University.
Trial summary
The purpose of this study is to examine the effects of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Curves Calcium and Calcium Carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 31 Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is female;
- Participant is post-menopausal;
- Participant is between the ages of 45 and 65;
- Participant is sedentary, overweight (BMI > 27) and post-menopausal;
Who cannot join
- Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, or thyroid disease;
- Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
- Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
- Participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (i.g., creatine, HMB, etc.), anabolic/catabolic hormone levels (i.e., androstenedione, DHEA, etc.) or weight loss (i.e., ephedra, thermogenics, etc.) within three months prior to the start of the study;
- Participant is consistently taking 500 mg or more of a Calcium supplement per day;
- Participant is receiving Hormone Replacement Therapy (HRT);
- Participant is involved in a planned exercise program within 3 - 6 months prior to the start of the study;
- Participant has lost > 20 lbs. within the last 3 - 6 months;
About this study
Official title: Effects of Calcium Supplementation on Body Composition, Metabolism and Exercise Capacity in Post-Menopausal Women Participating in the Curves for Women Fitness and Weight Loss Program
The purpose of this study is to examine the effects of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.
Read the detailed description
The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise \& Sport Nutrition Lab at Texas A\&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. However, we feel that the program may be even more effective with some additional nutritional interventions. Calcium has been shown to slow bone loss and more recently has been found to help promote fat loss. If this is the case, supplementing the diet with calcium may promote greater benefits in women participating in the Curves fitness/diet program. The purpose of this study is to examine the effect of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.
- Conditions
- Diet Modification
- Being tested
- Curves Calcium, Calcium Carbonate, Placebo
- Keywords
- Calcium Supplementation, Exercise Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curves CalciumDietary supplement
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).
Calcium CarbonateDietary supplement
Calcium (providing 950 mg/d as carbonate)
PlaceboDietary supplement
Dextrose placebo
| Study group | Role | What they receive |
|---|---|---|
| No Diet | Placebo comparator | No diet or exercise or calcium intervention Receives: Dietary Supplement: Curves Calcium; Dietary Supplement: Calcium Carbonate; Dietary Supplement: Placebo |
| High Calorie Diet | Experimental | High calorie (2,600 calorie) diet and exercise and calcium Receives: Dietary Supplement: Curves Calcium; Dietary Supplement: Calcium Carbonate; Dietary Supplement: Placebo |
| Low Carbohydrate/High Protein Diet | Experimental | Low carbohydrate (63% protein, 7% carbohydrate, 30% fat) diet and exercise and calcium Receives: Dietary Supplement: Curves Calcium; Dietary Supplement: Calcium Carbonate; Dietary Supplement: Placebo |
| High Carbohydrate/Low Protein | Experimental | High carbohydrate (15% protein, 55% carbohydrate, 30% fat) diet and exercise and calcium Receives: Dietary Supplement: Curves Calcium; Dietary Supplement: Calcium Carbonate; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition: Body Fat
Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Fat Free Mass
Changes in body composition (fat free mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Bone Mass
Changes in body composition (bone mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Fat Mass
Changes in body composition (fat mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Lean Mass
Changes in body composition (lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Body Weight
Changes in body weight (lbs. body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Energy Homeostasis: Resting Energy Expenditure (REE)
Changes in REE obtained via metabolic cart and expressed in absolute (kcals/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Energy Homeostasis: Respiratory Exchange Ratio (RER)
Changes in RER as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Secondary outcomes (69)
Muscular Strength: 1 Repetition Maximum (1RM) Bench Press
Changes in bench press 1RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Strength: 1 Repetition Maximum (1RM) Leg Press
Changes in leg press 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Bench Press Endurance Test
Changes in total repetitions at 80% of 1RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Leg Press Endurance Test
Changes in total repetitions at 80% of 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Body Composition: Body Water
Changes in body water obtained via Bioelectrical Impedance Analysis (BIA) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: Cholesterol
Changes in cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: HDL Cholesterol
Changes in HDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: LDL Cholesterol
Changes in LDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: Triglycerides
Changes in triglycerides obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Glucose
Changes in glucose obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Calcium
Changes in calcium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Albumin
Changes in albumin obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Total Protein
Changes in total protein obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Sodium
Changes in sodium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Potassium
Changes in potassium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Carbon Dioxide (CO2)
Changes in carbon dioxide (CO2) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Chloride
Changes in chloride obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Blood Urea Nitrogen (BUN)
Changes in blood urea nitrogen (BUN) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Creatinine
Changes in creatinine obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Alkaline Phosphatase (ALP)
Changes in alkaline phosphatase (ALP) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Amino Transferase (ALT)
Changes in alanine amino transferase (ALT) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Amino Transferase (AST)
Changes in alanine amino transferase (ALT) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Bilirubin
Changes in bilirubin obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: White Blood Cell (WBC) Count
Changes in white blood cell count (WBC) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: White Blood Cell Differential
Changes in white blood cell differential obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Red Blood Cell (RBC) Count
Changes in red blood cell count obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Red Cell Distribution Width (RDW)
Changes in red cell distribution width (RDW) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Hemoglobin
Changes in hemoglobin obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Hematocrit
Changes in hematocrit obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Platelet Count
Changes in platelet count obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Platelet Volume (MPV)
Changes in mean platelet volume (MPV) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Neutrophils
Changes in neutrophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Lymphocytes
Changes in lymphocytes obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Basophils
Changes in basophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Eosinophils
Changes in eosinophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Monocytes
Changes in monocytes obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Volume (MCV)
Changes in mean corpuscular volume (MCV) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Hemoglobin (MCH)
Changes in mean corpuscular hemoglobin (MCH) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Hemoglobin Concentration (MCHC)
Changes in mean corpuscular hemoglobin concentration (MCHC) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hormones: Insulin
Changes in serum insulin obtained from venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hormones: Leptin
Changes in serum leptin obtained from venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hemodynamic Variable: Resting Heart Rate (HR)
Changes in resting heart rate (HR) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)
Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Anthropometric Measures: Waist Circumference
Changes in waist circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Anthropometric Measures: Hip Circumference
Changes in hip circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Anthropometric Measures: Waist to Hip Ratio
Changes in the ratio of waist to hip (waist/hip circumference) analyzed with related anthropometric outcomes measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Anthropometric Measures: Body Mass Index
Change in body mass index (kg of body mass/height in meters squared) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Cardiac Variable: Resting Electrocardiogram (ECG)
Changes in resting ECG obtained via electrodes and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Exercise Capacity: Graded Exercise Test (GXT)
Changes in exercise capacity obtained via a treadmill test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Subjective Rating of Quality of Life
Changes in Quality of Life (QOL) obtained via SF36v2 questionnaire and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's). The SF-36 QOL inventory provides scores that assess physical functioning (i.e., ability to perform most vigorous physical activities without limitation to health); role physical (i.e., ability to work and perform daily activities); bodily pain (i.e., limitations due to pain); general health (i.e., assessment of personal health); vitality (i.e., feelings of energy); social functioning (i.e., ability to perform normal social activities); role emotion (i.e., problems with work or other daily activities); and, mental health (state of feelings of peacefulness, happiness, and calm) domains on a 0 (low) to 100 (high scale.
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Appetite
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of appetite using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Hunger
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of hunger using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Satisfaction from Food
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of satisfaction from food using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Feelings of Fullness
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of feelings of fullness using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Amount of Energy
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of amount of energy using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Subjective Rating of Overall Quality of Diet
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of overall quality of diet using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Dietary Energy Intake - Total Caloric Intake
Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Dietary Energy Intake - Carbohydrate
Change in dietary carbohydrate intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Dietary Energy Intake - Fat
Change in dietary fat intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Dietary Energy Intake - Protein
Change in dietary protein intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Dizziness
Change in perceptions of dizziness using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Headache
Change in perceptions of headache using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Tachycardia
Change in perceptions of tachycardia using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Palpitations
Change in perceptions of palpitations using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Dyspnea
Change in perceptions of dyspnea using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Nervousness
Change in perceptions of nervousness using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Blurred Vision
Change in perceptions of blurred vision using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Perceptions of Side Effects - Other Side Effects
Change in perceptions of other side effects using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Jan 2004
- Primary completion31 Dec 2005
- Study completion31 Dec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard B. Kreider, Texas A&M University
- Investigators
- Richard B Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878667
- Sponsor's protocol ID
- IRB2008-0643
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Calcium Supplementation on Body Composition, Metabolism and Exercise Capacity in Post-Menopausal Women Participating in the Curves for Women Fitness and Weight Loss Program
- ClinicalTrials.gov ID
- NCT03878667
- Acronym / sponsor ID
- IRB2008-0643
- Conditions
- Diet Modification
- Keywords
- Calcium Supplementation, Exercise Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Dec 2005 (actual)
- Study completion
- 31 Dec 2005 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.
Detailed description
The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise \& Sport Nutrition Lab at Texas A\&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. However, we feel that the program may be even more effective with some additional nutritional interventions. Calcium has been shown to slow bone loss and more recently has been found to help promote fat loss. If this is the case, supplementing the diet with calcium may promote greater benefits in women participating in the Curves fitness/diet program. The purpose of this study is to examine the effect of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Diet | Placebo comparator | Dietary Supplement: Curves Calcium, Dietary Supplement: Calcium Carbonate, Dietary Supplement: PlaceboNo diet or exercise or calcium intervention |
| High Calorie Diet | Experimental | Dietary Supplement: Curves Calcium, Dietary Supplement: Calcium Carbonate, Dietary Supplement: PlaceboHigh calorie (2,600 calorie) diet and exercise and calcium |
| Low Carbohydrate/High Protein Diet | Experimental | Dietary Supplement: Curves Calcium, Dietary Supplement: Calcium Carbonate, Dietary Supplement: PlaceboLow carbohydrate (63% protein, 7% carbohydrate, 30% fat) diet and exercise and calcium |
| High Carbohydrate/Low Protein | Experimental | Dietary Supplement: Curves Calcium, Dietary Supplement: Calcium Carbonate, Dietary Supplement: PlaceboHigh carbohydrate (15% protein, 55% carbohydrate, 30% fat) diet and exercise and calcium |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is female;
- Participant is post-menopausal;
- Participant is between the ages of 45 and 65;
- Participant is sedentary, overweight (BMI > 27) and post-menopausal;
Key exclusion criteria (8 listed)
- Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, or thyroid disease;
- Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
- Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
- Participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (i.g., creatine, HMB, etc.), anabolic/catabolic hormone levels (i.e., androstenedione, DHEA, etc.) or weight loss (i.e., ephedra, thermogenics, etc.) within three months prior to the start of the study;
- Participant is consistently taking 500 mg or more of a Calcium supplement per day;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curves CalciumCurves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron). | Dietary supplement | High Calorie Diet, High Carbohydrate/Low Protein, Low Carbohydrate/High Protein Diet, No Diet |
| Calcium CarbonateCalcium (providing 950 mg/d as carbonate) | Dietary supplement | High Calorie Diet, High Carbohydrate/Low Protein, Low Carbohydrate/High Protein Diet, No Diet |
| PlaceboDextrose placebo | Dietary supplement | High Calorie Diet, High Carbohydrate/Low Protein, Low Carbohydrate/High Protein Diet, No Diet |
Primary outcome
Body Composition: Body Fat
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Body Composition: Fat Free Mass
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (fat free mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Body Composition: Bone Mass
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (bone mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Body Composition: Fat Mass
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (fat mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Body Composition: Lean Mass
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Body Composition: Body Weight
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body weight (lbs. body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Energy Homeostasis: Resting Energy Expenditure (REE)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in REE obtained via metabolic cart and expressed in absolute (kcals/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Energy Homeostasis: Respiratory Exchange Ratio (RER)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in RER as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
69 secondary outcomes
Muscular Strength: 1 Repetition Maximum (1RM) Bench Press
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Strength: 1 Repetition Maximum (1RM) Leg Press
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Bench Press Endurance Test
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Leg Press Endurance Test
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Body Composition: Body Water
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: Cholesterol
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: HDL Cholesterol
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: LDL Cholesterol
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Lipid Panel: Triglycerides
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Glucose
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Calcium
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Albumin
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Total Protein
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Sodium
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Potassium
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Carbon Dioxide (CO2)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Chloride
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Blood Urea Nitrogen (BUN)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Creatinine
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Alkaline Phosphatase (ALP)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Amino Transferase (ALT)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Amino Transferase (AST)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Comprehensive Metabolic Panel - CMP: Bilirubin
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: White Blood Cell (WBC) Count
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: White Blood Cell Differential
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Red Blood Cell (RBC) Count
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Red Cell Distribution Width (RDW)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Hemoglobin
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Hematocrit
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Platelet Count
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Platelet Volume (MPV)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Neutrophils
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Lymphocytes
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Basophils
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Eosinophils
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Monocytes
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Volume (MCV)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Hemoglobin (MCH)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Complete Blood Count - CBC: Mean Corpuscular Hemoglobin Concentration (MCHC)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Hormones: Insulin
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Kreider, PhD principal investigator
Texas A&M University
Questions about this trial
What is this clinical trial studying?
A study testing Curves Calcium and Calcium Carbonate in people with Diet Modification, run by Texas A&M University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition: Body Fat (time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.