Prebiotic Fiber as a Modifier of Satiety Hormones and Body Weight in Overweight and Obese Adults

Study Overview
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Brief Summary
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The purpose of this study is to determine if oligofructose supplementation promotes weight loss in overweight and obese adults.

Detailed Description
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Obesity is a primary health concern for many western countries as it is linked to several chronic diseases as well as, large health care costs. Although obesity is a multifactorial disease, it is known that levels of satiety hormones including glucagon like peptide-1 (GLP-1) and peptide YY (PYY) are reduced in obesity. The ability of prebiotic fiber to promote weight loss through the production of satiety hormones has been tested previously using rodents. Here it was found that prebiotic supplementation resulted in a decreased energy intake, higher GLP-1 levels in the plasma and increased proglucagon mRNA levels in the gut. This study will address the important question of whether prebiotic fiber supplementation is effective in reducing body weight in overweight or obese human subjects.

Official Title
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Effect of Oligofructose Versus Placebo on Body Weight and Satiety Hormone Secretion in Overweight and Obese Adults.

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Oligofructose
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight or class I obese individuals with BMI between 25 kg/m2 and 34.9 kg/m2 stable body weight in previous 3 months Exclusion Criteria: Type 1 and Type 2 diabetes clinically significant cardiovascular abnormalities liver or pancreas disease major gastrointestinal surgeries are pregnant or lactating exhibit alcohol or drug dependence on drugs influencing appetite are following a diet or exercise regime designed for weight loss have a body mass greater than 350lb chronic use of antacids or bulk laxatives

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oligofructose | Dietary Supplement: Oligofructose<br>* 21 grams per day in distributed over 3 doses per day for 3 months<br>* Other names: Raftilose P95;|
| Placebo Comparator: 2<br>Placebo | Dietary Supplement: Placebo<br>* 7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months<br>* Other names: Maltrin M100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma satiety hormones |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, weight loss, satiety hormones, body composition, appetite ratings