Weight LossNB14NCT03395262
An Examination of a Weight Loss Formula on Health
A study testing Active with caffeine and Active without caffeine in people with Weight Loss, run by Texas A&M University at 1 site in United States.
Trial summary
The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk. Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Active with caffeine and Active without caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 31 Dec 2018
- 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 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 25 and 34.9
Who cannot join
- Recent history of weight change (+/- 10 lbs. within the past 3 months)
- Uncontrolled metabolic disorders
- Uncontrolled cardiovascular disorders
- Currently taking prescription medications (birth control is allowed)
- Currently taking dietary supplements for weight loss
- Pregnant or plan to become pregnant
- Have an intolerance to caffeine or other natural stimulants
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise & Sport Nutrition Lab - Human Clinical Research Facility
College Station, Texas, 77845
About this study
Official title: An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk
The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.
Read the detailed description
Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.
- Conditions
- Weight Loss
- Being tested
- Active with caffeine, Active without caffeine, 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.
Active with caffeineDietary supplement
Novel formula with caffeine
Active without caffeineDietary supplement
Novel formula without caffeine
PlaceboDietary supplement
Dextrose placebo
| Study group | Role | What they receive |
|---|---|---|
| Active with caffeine | Experimental | Novel formula with caffeine Receives: Dietary Supplement: Active with caffeine |
| Active without caffeine | Active comparator | Novel formula without caffeine Receives: Dietary Supplement: Active without caffeine |
| Placebo | Placebo comparator | Dextrose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition - Weight
Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Body Composition - Fat Mass
Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Body Composition - Body Fat Percent
Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Secondary outcomes (69)
Body Composition - Lean Tissue Mass
Change in lean tissue mass (kg) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Body Composition - Bone Mass
Change in bone mass (g) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Body Composition - Fat Free Mass
Changes in fat free mass (sum of lean tissue mass and bone mass expressed in kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Body Composition - Total Body Water
Change in total body water (L and %) and analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Resting Energy Expenditure - Caloric Expenditure
Change in resting energy expenditure expressed in absolute (kcals/d) and relative terms (kcals/kg/day) and analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Resting Energy Expenditure - Respiratory Exchange Ratio
Change in resting respiratory exchange ratio (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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Anthropometric Measures - Waist Circumference
Change in waist circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Anthropometric Measures - Hip Circumference
Change in hip circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Anthropometric Measures - Waist to Hip Ratio
Change in the ratio of waist to hip (waist / hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Heart Rate
Changes in resting heart rate (bpm) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Systolic Blood Pressure
Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Diastolic Blood Pressure
Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose
Change in blood glucose (mg/dl) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin
Change in fasting insulin (µIU/mL) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance
Change in Homeostatic Model Assessment of Insulin Resistance (Fasting insulin x Fasting glucose / 405) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Triglyderides
Change in triglycerides (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol
Change in total cholesterol (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins
Change in high density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins
Change in low density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio
Change in the ratio of total cholesterol to high density lipoproteins (HDL) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Creatinine
Change in creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen
Change in blood urea nitrogen (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio
Change in the ratio of blood urea nitrogen (mg/dl) to creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase
Change in alkaline phosphatase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase
Change in alanine amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase
Change in aspartate amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase
Change in creatine kinase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase
Change in lactate dehydrogenase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells
Change in white blood cells (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes
Change in lymphocytes (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count
Change in mid-range count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte
Change in granulocyte count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells
Change in red cell count (M/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin
Change in hemoglobin (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit
Change in hematocrit (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Volume
Change in mean corpuscular volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin
Change in mean corpuscular hemoglobin (pg/cell) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin Concentration
Change in mean corpuscular hemoglobin concentration (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution Width
Change in red cell distribution width (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet Count
Change in platelet count (x103/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet Volume
Change in mean platelet volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Appetite Hormone - Leptin
Change in leptin levels (ng/ml) analyzed via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Work Domain
Change in IPAQ work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Active Transportation Domain
Change in IPAQ active transportation domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work Domain
Change in IPAQ domestic and garden/yard work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Leisure-Time Domain
Change in IPAQ leisure-time domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
International Physical Activity Questionnaire (IPAQ) - Total Physical Activity Score
Change in IPAQ leisure time domain (Total physical activity MET-minutes/week = sum of Total Work + Total Transport + Total Domestic and Garden + Total Leisure-Time MET-minutes/week scores) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Appetite
Changes in perceptions of appetite assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Hunger
Changes in perceptions of hunger assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Satisfaction with Food
Changes in perceptions of satisfaction with food assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Feelings of Fullness
Changes in perceptions of feelings of fullness assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Satiety Questionnaire - Perceptions of Diet / Eating Satisfaction
Changes in perceptions of diet / eating satisfaction assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Sleep Quality Questionnaire - Sleep Duration
Changes in average reported sleep duration over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Sleep Quality Questionnaire - Sleep Quality
Changes in rating of sleep quality over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Sleep Quality Questionnaire - Enthusiasm
Changes in rating of enthusiasm over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Sleep Quality Questionnaire - Sleep Disturbances
Changes in rating of sleep disturbances over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 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 and mean changes from baseline with 95% confidence intervals (CI's).
Measured: Measured every 4 weeks for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start1 Jun 2017
- Primary completion31 Mar 2018
- Study completion31 Dec 2018
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT03395262
- Sponsor's protocol ID
- IRB2016-0829FX
- Acronym
- NB14
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 10 Sep 2019
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT03395262
- Acronym / sponsor ID
- NB14 / IRB2016-0829FX
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Jan 2018 (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 aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.
Detailed description
Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active with caffeine | Experimental | Dietary Supplement: Active with caffeineNovel formula with caffeine |
| Active without caffeine | Active comparator | Dietary Supplement: Active without caffeineNovel formula without caffeine |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDextrose |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) between 25 and 34.9
Key exclusion criteria (7 listed)
- Recent history of weight change (+/- 10 lbs. within the past 3 months)
- Uncontrolled metabolic disorders
- Uncontrolled cardiovascular disorders
- Currently taking prescription medications (birth control is allowed)
- Currently taking dietary supplements for weight loss
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 |
|---|---|---|
| Active with caffeineNovel formula with caffeine | Dietary supplement | Active with caffeine |
| Active without caffeineNovel formula without caffeine | Dietary supplement | Active without caffeine |
| PlaceboDextrose placebo | Dietary supplement | Placebo |
Primary outcome
Body Composition - Weight
Time frame: Measured every 4 weeks for 12 weeks
Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Body Composition - Fat Mass
Time frame: Measured every 4 weeks for 12 weeks
Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Body Composition - Body Fat Percent
Time frame: Measured every 4 weeks for 12 weeks
Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
69 secondary outcomes
Body Composition - Lean Tissue Mass
Time frame: Measured every 4 weeks for 12 weeks
Body Composition - Bone Mass
Time frame: Measured every 4 weeks for 12 weeks
Body Composition - Fat Free Mass
Time frame: Measured every 4 weeks for 12 weeks
Body Composition - Total Body Water
Time frame: Measured every 4 weeks for 12 weeks
Resting Energy Expenditure - Caloric Expenditure
Time frame: Measured every 4 weeks for 12 weeks
Resting Energy Expenditure - Respiratory Exchange Ratio
Time frame: Measured every 4 weeks for 12 weeks
Anthropometric Measures - Waist Circumference
Time frame: Measured every 4 weeks for 12 weeks
Anthropometric Measures - Hip Circumference
Time frame: Measured every 4 weeks for 12 weeks
Anthropometric Measures - Waist to Hip Ratio
Time frame: Measured every 4 weeks for 12 weeks
Anthropometric Measures - Body Mass Index
Time frame: Measured every 4 weeks for 12 weeks
Dietary Energy Intake - Total Caloric Intake
Time frame: Measured every 4 weeks for 12 weeks
Dietary Energy Intake - Carbohydrate
Time frame: Measured every 4 weeks for 12 weeks
Dietary Energy Intake - Fat
Time frame: Measured every 4 weeks for 12 weeks
Dietary Energy Intake - Protein
Time frame: Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Heart Rate
Time frame: Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Systolic Blood Pressure
Time frame: Measured every 4 weeks for 12 weeks
Resting Hemodynamics - Diastolic Blood Pressure
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Triglyderides
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Creatinine
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin
Time frame: Measured every 4 weeks for 12 weeks
Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit
Time frame: Measured every 4 weeks for 12 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 10 Sep 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active with caffeine and Active without caffeine 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 1 inclusion and 7 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 10 Sep 2019. 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 - Weight (time frame: Measured every 4 weeks for 12 weeks). The study lists 3 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 10 Sep 2019.