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Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight

This study has been completed.
Sponsor:
Collaborators:
University of British Columbia
InovoBiologic Inc.
Information provided by:
Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier:
NCT01109199
First received: April 20, 2010
Last updated: April 15, 2011
Last verified: April 2011
History of Changes
  Purpose

This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female.

The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a 14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the rice flour supplementation of the LCD.


Condition Intervention Phase
Appetite Suppression
Weight Loss
 Dietary Supplement: PolyGlycopleX (PGX)
Dietary Supplement: Rice flour
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre (PGX) Supplementation of a Low Calorie Diet on Appetite and Body Weight, in Overweight and Moderately Obese Females

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Canadian Center for Functional Medicine:

Primary Outcome Measures:
  • The difference in appetite score assessed from appetite Visual Analog Scale [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in weight (kilograms) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Change in percentage of body fat [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PolyGlycopleX (PGX) Dietary Supplement: PolyGlycopleX (PGX)
The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
Placebo Comparator: Rice Flour Dietary Supplement: Rice flour
The full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 25 - 35 Kg/m2

Exclusion Criteria:

  • Medications and supplements that affect appetite
  • Known diabetes
  • Contraindications to LCD
  • Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109199

Locations
Canada, British Columbia
Canadian Center for Functional Medicine
Coquitlam, British Columbia, Canada, V3K 6Y7
Canadian Center for Functional Medicine
Coquitlam, British Columbia, Canada
Sponsors and Collaborators
Canadian Center for Functional Medicine
University of British Columbia
InovoBiologic Inc.
Investigators
Principal Investigator: Michael R Lyon, M.D. Canadian Center for Functional Medicine
  More Information

No publications provided

Responsible Party: Scientific Officer, InovoBiologic Inc.
ClinicalTrials.gov Identifier: NCT01109199     History of Changes
Other Study ID Numbers: PGX RCT Study
Study First Received: April 20, 2010
Last Updated: April 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by Canadian Center for Functional Medicine:
viscous
fibre
polysaccharide
appetite
 hunger
satiety
weight management

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 22, 2013