A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults (NCT04782024) | Clinical Trial Compass
CompletedPhase 2
A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
United States138 participantsStarted 2015-09-30
Plain-language summary
This study will investigate the effect of two different doses of 7-Keto compared to placebo on resting metabolic rate. One third of subjects will be given the lower 7-Keto dose, one third will be given the higher 7-Keto dose and one third will be given the placebo.
Who can participate
Age range20 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female 20 to 55 years of age
✓. If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation).
✓. If female and currently experiencing menstrual cycles, subjects should have regular menstrual cycles (28 ± 2 days) and must be in their follicular phase during the duration of the study period (i.e. baseline to visit 3)
✓. BMI 25-34.9 ±1 kg/m2
✓. Stable weight defined as less than 5kg (approx. 11lbs) gained or lost in the past 3 months
✓. Sedentary subjects; defined as subjects with a desk/inactive job, not engaging in any regular sports or exercise programs either at an exercise facility or at home. Occasional activity, low intensity yoga and walking at a regular pace are acceptable.
✓. Agreement to maintain current level of physical activity through the study and avoid exercising 24 hours prior to study visits
✓. Agreement to adopt a diet with a 500 kcal reduction for the duration of the study period.
Exclusion criteria
✕. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
✕. Immunodeficiency (i.e. HIV positive, rheumatoid arthritis, history of organ transplant)
✕. Use of prescription, over-the-counter, or natural health products known to affect weight and/or metabolic rate within 4 weeks of randomization and during the trial
✕. Type I or II diabetes, metabolic disease or any condition that in the opinion of the Qualified Investigator does not safely allow for a reduction in calorie intake
✕. Any evidence of an eating disorder, such as anorexia or bulimia, or the presence of any illness that might represent a potential cause of weight loss