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OpenTrials
Completed

NCT Number: NCT00522353

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

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

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research

Calgary, Alberta, T2N 1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oligofructose

Dietary Supplement

21 grams per day in distributed over 3 doses per day for 3 months

Other names: Raftilose P95

Placebo

Dietary Supplement

7.89 grams of placebo maltodextrin divided into 3 equal doses per day for 3 months

Other names: Maltrin M100

Primary outcomes

  1. Body weight

    Time frame: 3 months

Secondary outcomes

  1. Plasma satiety hormones

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 29, 2007
Registry last updated
May 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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