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

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ClinicalTrials.gov Identifier: NCT01109199
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : October 2, 2015
Sponsor:
Collaborators:
University of British Columbia
InovoBiologic Inc.
Information provided by (Responsible Party):
Canadian Center for Functional Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Appetite Suppression Weight Loss Dietary Supplement: PolyGlycopleX (PGX) Dietary Supplement: Rice flour Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. The difference in appetite score assessed from appetite Visual Analog Scale [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Change in weight (kilograms) [ Time Frame: 18 weeks ]
  2. Change in percentage of body fat [ Time Frame: 18 weeks ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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.

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): 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

Responsible Party: Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier: NCT01109199     History of Changes
Other Study ID Numbers: PGX RCT Study
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

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