An interventional study of Active with caffeine and Active without caffeine in Weight Loss, sponsored by Texas A&M University. Completed at 1 site in United States. Open to participants aged 30 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by Texas A&M University · Not applicable, Interventional, and Health services research
Among 995 studies in Weight Loss with a site in United States — 114 open to participants now, 169 under way, 6 of them phase 3. Weight Loss · United States.
Among the 995 studies in Weight Loss with a site in United States, this one is the 422nd largest by enrollment of the 912 interventional ones that give a count, is one of 62 that started in 2017, is one of 714 with no phase, and was the 572nd registered.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
Browse Weight Loss studies →114 of the 995 studies in Weight Loss with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Icahn School of Medicine at Mount Sinai · Sites in United States
Morehouse School of Medicine · Sites in United States
Duke University · Sites in United States
Viking Therapeutics, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.
This study: 30 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
995 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 106 · Phase 3 38 · Phase 4 33
First in 1996; this study’s year is marked. 62 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is close to the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Median enrollment 72 across the 912 interventional studies, 99 across the 76 observational. Of the 769 that completed or were terminated, 230 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
116 of 995 have an industry lead sponsor. The 10 most frequent:
Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Texas A&M University has 3 studies filed under Weight Loss — fewer than ten, so there is no comparison to draw.
57 of the studies in Weight Loss with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07298915Phase 3University of VirginiaThe Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED) | 2026-12 |
| NCT07223242Phase 3University of Texas Southwestern Medical CenterTailored Exercise Training Study Among Adults With HFpEF | 2026-12-30 |
| NCT07104383Phase 3Viking Therapeutics, Inc.VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) | 2027-07-01 |
| NCT07104500Phase 3Viking Therapeutics, Inc.VK2735 for Weight Management Phase 3 | 2027-07-01 |
| NCT07560579Million Marker Wellness, Inc.Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity | 2026-11 |
Among the 995 studies in Weight Loss with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Novel formula with caffeine
Dietary Supplement: Active with caffeine
Novel formula without caffeine
Dietary Supplement: Active without caffeine
Dextrose
Dietary Supplement: Placebo
Drug page: Caffeine
Novel formula with caffeine
Novel formula without caffeine
Dextrose placebo
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).
Time frame: 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).
Time frame: 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).
Time frame: Measured every 4 weeks for 12 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Measured every 4 weeks for 12 weeks
Plan to share: No
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Ran from Jun 2017 to primary completion in Mar 2018, 9 months.
Of 670 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 9 months is below that.
Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Caffeine