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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522353
• Other study ID #: UC 20085
• Status: Completed
• Phase: N/A
• First received: August 27, 2007
• Last updated: May 21, 2008
• Start date: January 2007
• Est. completion date: August 2007

Study information

• Verified date: May 2008
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

Dietary Supplement:
• Oligofructose
21 grams per day in distributed over 3 doses per day for 3 months
• Placebo
7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months

Locations

Country	Name	City	State
Canada	Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		3 months	No
Secondary	Plasma satiety hormones		3 months	No