Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition
Phase 2
Completed
- Conditions
- Obesity
- Registration Number
- NCT01272739
- Lead Sponsor
- Avera McKennan Hospital & University Health Center
- Brief Summary
This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight loss, and changes in body composition.
- Detailed Description
Subjects will be randomized to one of two groups: one group will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; the other group will take placebo 15 minutes prior to the three main meals of the day. Subjects will be on the investigational product or placebo for 12 weeks. Participation in this study involves four study visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Age 18 and older
- Body mass index of 30 or greater
- Agree to keep diet, exercise and all current health habits stable during participation in the study
Exclusion Criteria
- Women who are pregnant, breastfeeding or planning to become pregnant
- Prior bariatric surgery
- Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
- Obesity as a result of a clinically diagnosed endocrine problem
- Currently taking an anti-psychotic medication
- History of peptic ulcer disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Weight 12 weeks
- Secondary Outcome Measures
Name Time Method Body composition 12 weeks
Trial Locations
- Locations (1)
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Avera Research Institute🇺🇸Sioux Falls, South Dakota, United States