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

September 30, 2015 updated by: Canadian Center for Functional Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • Canadian Center for Functional Medicine
      • Coquitlam, British Columbia, Canada, V3K 6Y7
        • Canadian Center for Functional Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference in appetite score assessed from appetite Visual Analog Scale
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in weight (kilograms)
Time Frame: 18 weeks
18 weeks
Change in percentage of body fat
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Center for Functional Medicine

Collaborators

University of British Columbia
InovoBiologic Inc.

Investigators

  • Principal Investigator: Michael R Lyon, M.D., Canadian Center for Functional Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (ESTIMATE)

April 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGX RCT Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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