Evaluation of Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX)

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

A Prospective, Single Crossover, Randomized, Double Blind Placebo Controlled Trial Evaluating Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX) vs. Rice Flour Control, in Overweight and Moderately Obese Females.

The objective of the study is to compare subjective appetite ratings and after-meal and 24 hour blood glucose levels within overweight and obese female subjects consuming either a standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length and separated by 3 week washout phase, so subjects will also be acting as their own control. Subjects will be randomized to either start with the low calorie diet with PGX or the low calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour placebo control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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, V3K6Y2
        • Canadian Centre 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 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- BMI 25-35 Kg/m2

Exclusion Criteria:

  • Known diabetes
  • Medications or natural health products that affect appetite
  • 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: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PolyGlycopleX (PGX)
5 grams of PGX 3 times per day with each main meal (breakfast, lunch and dinner)
Dietary supplement: PolyGlycopleX (PGX)
powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days
PLACEBO_COMPARATOR: Rice flour
5 grams of rice flour 3 times per day at each main meal (breakfast, lunch and dinner)
Dietary supplement: PolyGlycopleX (PGX)
powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles.
Time Frame: 3 days
3 days

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 Lyon, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (ESTIMATE)

April 22, 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

Other Study ID Numbers

  • PGX Crossover 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.

Clinical Trials on Blood Glucose, Postprandial

Clinical Trials on PolyGlycopleX (PGX)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe