Weight LossC-30NCT04344821
Curves 30/30 Study
A study testing Curves Calcium in people with Weight Loss, run by Texas A&M University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Curves Calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2009to 3 May 2012
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is female;
- Participant is post-menopausal;
- Participant is between the ages of 18 and 45;
- Participant is sedentary, overweight (BMI > 27) and post-menopausal;
Who cannot join
- Participant has any metabolic disorders 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.e., 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise & Sport Nutrition Laboratory
College Station, Texas, 77843
About this study
Official title: Effects of Repeated Short-Term Diets on Weight Loss in Women Participating in the Curves Fitness Program
The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.
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 Laboratory (ESNL) 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 and diet program. The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.
- Conditions
- Weight Loss
- Being tested
- Curves Calcium, Placebo
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curves CalciumDietary supplement
Dietary Supplement: Curves Calcium
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU 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)
PlaceboDietary supplement
Dextrose Placebo
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No diet or exercise intervention Receives: Dietary Supplement: Curves Calcium; Dietary Supplement: Placebo |
| No Diet plus Exercise | Experimental | No diet, exercise only intervention Receives: Dietary Supplement: Curves Calcium; Dietary Supplement: Placebo |
| High Protein Diet plus Exercise | Experimental | High protein diet and exercise intervention Receives: Dietary Supplement: Curves Calcium; Dietary Supplement: Placebo |
| High Carbohydrate Diet plus Exercise | Experimental | High carbohydrate diet and exercise intervention Receives: Dietary Supplement: Curves Calcium; 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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
Body Composition: Body Weight
Changes in body composition (body weight) 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), and after 1, 2, 3, 4, 5 and 6 months
Secondary outcomes (20)
Energy Homeostasis: Resting Energy Expenditure (REE)
Changes in REE obtained via metabolic cart and expressed in absolute (kcal/d) and relative terms kcals/kg/d) 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), and after 1, 2, 3, 4, 5 and 6 months
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 change from baseline with 95% confidence intervals (CI's)
Measured: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Changes in bench press 1 RM 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), and after 3, and 6 months
Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Changes in bench press 1 RM 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), and after 3, and 6 months
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Changes in total repetitions at 80% of 1 RM 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), and after 3, and 6 months
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Changes in total repetitions at 80% of 1 RM 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), and after 3, and 6 months
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), and after 3, and 6 months
Cardiac Variable: 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), and after 3, and 6 months
Hemodynamic Variable: Resting Heart Rate (RHR)
Changes in resting heart rae (RHR) 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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
Anthropometric Measures: Waist to Hip Ratio
Changes in the ratio of waist to hip (waist/hip circumference) 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), and after 1, 2, 3, 4, 5 and 6 months
Fasting 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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
Lipid Panel: Cholesterol to HDL Ratio
Changes in cholesterol to HDL ratio 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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start18 May 2009
- Primary completion3 May 2012
- Study completion3 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Model description
- Randomized, placebo controlled, repeated measures intervention trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Curves International
- Responsible party
- Principal investigator, Richard B. Kreider, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344821
- Sponsor's protocol ID
- IRB2008-0480
- Acronym
- C-30
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repeated Short-Term Diets on Weight Loss in Women Participating in the Curves Fitness Program
- ClinicalTrials.gov ID
- NCT04344821
- Acronym / sponsor ID
- C-30 / IRB2008-0480
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Curves International
- Study start
- 18 May 2009
- Primary completion
- 3 May 2012 (actual)
- Study completion
- 3 May 2012 (actual)
- First posted
- 14 Apr 2020 (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 determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.
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 Laboratory (ESNL) 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 and diet program. The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Randomized, placebo controlled, repeated measures intervention trial
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Curves Calcium, Dietary Supplement: PlaceboNo diet or exercise intervention |
| No Diet plus Exercise | Experimental | Dietary Supplement: Curves Calcium, Dietary Supplement: PlaceboNo diet, exercise only intervention |
| High Protein Diet plus Exercise | Experimental | Dietary Supplement: Curves Calcium, Dietary Supplement: PlaceboHigh protein diet and exercise intervention |
| High Carbohydrate Diet plus Exercise | Experimental | Dietary Supplement: Curves Calcium, Dietary Supplement: PlaceboHigh carbohydrate diet and exercise intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant is female;
- Participant is post-menopausal;
- Participant is between the ages of 18 and 45;
- Participant is sedentary, overweight (BMI > 27) and post-menopausal;
Key exclusion criteria (8 listed)
- Participant has any metabolic disorders 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.e., 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 CalciumDietary Supplement: Curves Calcium Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU 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 | Control, High Carbohydrate Diet plus Exercise, High Protein Diet plus Exercise, No Diet plus Exercise |
| PlaceboDextrose Placebo | Dietary supplement | Control, High Carbohydrate Diet plus Exercise, High Protein Diet plus Exercise, No Diet plus Exercise |
Primary outcome
Body Composition: Body Fat
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
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), and after 1, 2, 3, 4, 5 and 6 months
Changes in body composition (body weight) 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)
20 secondary outcomes
Energy Homeostasis: Resting Energy Expenditure (REE)
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Energy Homeostasis: Respiratory Exchange Ratio (RER)
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months
Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months
Cardiac Variable: Resting Electrocardiogram (ECG)
Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months
Cardiac Variable: Graded Exercise Test (GXT)
Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months
Hemodynamic Variable: Resting Heart Rate (RHR)
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Anthropometric Measures: Waist Circumference
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Anthropometric Measures: Hip Circumference
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Anthropometric Measures: Waist to Hip Ratio
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Fasting Glucose
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Lipid Panel: Cholesterol
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Lipid Panel: HDL Cholesterol
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Lipid Panel: Cholesterol to HDL Ratio
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Lipid Panel: LDL Cholesterol
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Lipid Panel: Triglycerides
Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
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 15 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curves Calcium in people with Weight Loss, run by Texas A&M University at 1 site in United States.
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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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), and after 1, 2, 3, 4, 5 and 6 months). The study lists 6 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 15 Apr 2020.