Skip to main content
OpenTrials
Completed

NCT Number: NCT01108328

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Canadian Center for Functional Medicine, Coquitlam, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PolyGlycopleX (PGX)

Dietary Supplement

powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days

Primary outcomes

  1. Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.

    Time frame: 3 days

Secondary outcomes

  1. Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles.

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Canadian Center for Functional Medicine

Other

Collaborators

  • InovoBiologic Inc.
  • University of British Columbia

Registry information

Official study title

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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 22, 2010
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.