Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of IHBG-10 on Weight Loss and Body Composition

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: IHBG-10
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day. | Dietary Supplement: IHBG-10<br>* 500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day<br>* Other names: IHBG10;|
| Placebo Comparator: Control Group<br>Subjects will take a placebo 15 minutes prior to the three main meals of the day. | Dietary Supplement: Placebo<br>* Placebo taken 15 minutes prior to the three main meals of the day<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutriceutical, obesity, weight loss, weight management, overweight