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

This study has been completed.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00522353
First received: August 27, 2007
Last updated: May 21, 2008
Last verified: May 2008
History of Changes
  Purpose

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


Condition Intervention
Obesity
 Dietary Supplement: Oligofructose
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Oligofructose Versus Placebo on Body Weight and Satiety Hormone Secretion in Overweight and Obese Adults.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma satiety hormones [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2007
Study Completion Date: August 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Oligofructose
 Dietary Supplement: Oligofructose
21 grams per day in distributed over 3 doses per day for 3 months
Other Name: Raftilose P95
Placebo Comparator: 2
Placebo
 Dietary Supplement: Placebo
7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months
Other Name: Maltrin M100

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522353

Locations
Canada, Alberta
Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Raylene A. Reimer, PhD, RD University of Calgary
  More Information

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Raylene Reimer, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00522353     History of Changes
Other Study ID Numbers: UC 20085
Study First Received: August 27, 2007
Last Updated: May 21, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
obesity
weight loss
satiety hormones
body composition
appetite ratings

Additional relevant MeSH terms:
Body Weight
Obesity
Overweight
Signs and Symptoms
Overnutrition
 Nutrition Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013