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

May 21, 2008 updated by: University of Calgary

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Dietary supplement: Placebo
7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months
Other Names:
  • Maltrin M100
ACTIVE_COMPARATOR: 1
Oligofructose
Dietary supplement: Oligofructose
21 grams per day in distributed over 3 doses per day for 3 months
Other Names:
  • Raftilose P95

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma satiety hormones
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (ESTIMATE)

August 29, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2008

Last Update Submitted That Met QC Criteria

May 21, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC 20085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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