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

Primary Purpose

Appetite Suppression, Weight Loss

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
PolyGlycopleX (PGX)
Rice flour
Sponsored by
Canadian Center for Functional Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appetite Suppression focused on measuring viscous, fibre, polysaccharide, appetite, hunger, satiety, weight management

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Canadian Center for Functional Medicine
  • Canadian Center for Functional Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PolyGlycopleX (PGX)

Rice Flour

Arm Description

Outcomes

Primary Outcome Measures

The difference in appetite score assessed from appetite Visual Analog Scale

Secondary Outcome Measures

Change in weight (kilograms)
Change in percentage of body fat

Full Information

First Posted
April 20, 2010
Last Updated
September 30, 2015
Sponsor
Canadian Center for Functional Medicine
Collaborators
University of British Columbia, InovoBiologic Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01109199
Brief Title
Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Center for Functional Medicine
Collaborators
University of British Columbia, InovoBiologic Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite Suppression, Weight Loss
Keywords
viscous, fibre, polysaccharide, appetite, hunger, satiety, weight management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PolyGlycopleX (PGX)
Arm Type
Experimental
Arm Title
Rice Flour
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
PolyGlycopleX (PGX)
Intervention Description
The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Rice flour
Intervention Description
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 Measure Information:
Title
The difference in appetite score assessed from appetite Visual Analog Scale
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Change in weight (kilograms)
Time Frame
18 weeks
Title
Change in percentage of body fat
Time Frame
18 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Lyon, M.D.
Organizational Affiliation
Canadian Center for Functional Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Center for Functional Medicine
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 6Y7
Country
Canada
Facility Name
Canadian Center for Functional Medicine
City
Coquitlam
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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

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