Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition
NCT ID: NCT01272739
Last Updated: 2011-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2011-02-28
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Study Group
Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day.
IHBG-10
500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day
Control Group
Subjects will take a placebo 15 minutes prior to the three main meals of the day.
Placebo
Placebo taken 15 minutes prior to the three main meals of the day
Interventions
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IHBG-10
500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day
Placebo
Placebo taken 15 minutes prior to the three main meals of the day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Avera McKennan Hospital & University Health Center
OTHER
Responsible Party
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Principal Investigators
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Edward Zawada, MD
Role: PRINCIPAL_INVESTIGATOR
Avera McKennan Hospital & University Health Center
Locations
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Avera Research Institute
Sioux Falls, South Dakota, United States
Countries
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Other Identifiers
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ARI-1300-IHBG10
Identifier Type: -
Identifier Source: org_study_id