Anti-psychotic Medication (New Use) Weight Loss Study

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 change and changes in body composition in subjects who have just started taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel, and/or Zyprexa).

Detailed Description
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A total of 30 subjects will be enrolled in this study. They will be randomized in to one of two groups. One group (of 20 subjects) will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. The other group (of 10 subjects) will take a placebo 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. Subjects will take the investigational product or placebo for 12 weeks. Participation in this study involves 4 study visits.

Official Title
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Surveillance Study of Weight Response and Body Composition in Subjects Who Are First-Time Users (Less Than 3 Months) of the Following Medications: Risperdal, Seroquel, and/or Zyprexa, in Combination With 500 mg IHBG-10 TID

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: Men and women, age 18 and older Agree to keep diet, exercise and all current health habits stable during participation in the study Have been taking Risperdal (Risperidone), Seroquel (Quetiapine), or Zyprexa (Olanzapine) for less than 3 months Exclusion Criteria: Current active acute psychotic episode 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

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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No

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 IHBG-10 15 minutes prior to the three main meals of the day. | Dietary Supplement: IHBG-10<br>* 500 mg IHBG-10<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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obesity, weight loss, weight management, anti-psychotic medication, nutriceutical