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

This study has been completed.
Sponsor:
Collaborators:
University of British Columbia
InovoBiologic Inc.
Information provided by:
Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier:
NCT01108328
First received: April 20, 2010
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Appetite and Hunger, Suppression
Blood Glucose, Postprandial
Dietary Supplement: PolyGlycopleX (PGX)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Canadian Center for Functional Medicine:

Primary Outcome Measures:
  • Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108328

Locations
Canada, British Columbia
Canadian Centre for Functional Medicine
Coquitlam, British Columbia, Canada, V3K6Y2
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 Lyon, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Scientific Officer, InovoBiologic Inc.
ClinicalTrials.gov Identifier: NCT01108328     History of Changes
Other Study ID Numbers: PGX Crossover Study
Study First Received: April 20, 2010
Last Updated: November 30, 2010
Health Authority: Canada: Health Canada

Keywords provided by Canadian Center for Functional Medicine:
viscous
fibre
polysaccharide
blood glucose
postprandial
appetite
hunger
satiety

Additional relevant MeSH terms:
Epoprostenol
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014