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

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ClinicalTrials.gov Identifier: NCT00522353
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : May 23, 2008
Sponsor:
Information provided by:
University of Calgary

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

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Oligofructose Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Oligofructose Versus Placebo on Body Weight and Satiety Hormone Secretion in Overweight and Obese Adults.
Study Start Date : January 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Body weight [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Plasma satiety hormones [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs