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

Blood Glucose, Postprandial Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108328
• Other study ID #: PGX Crossover Study
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2010
• Last updated: September 30, 2015
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: September 2015
• Source: Canadian Center for Functional Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Appetite and Hunger, Suppression
• Blood Glucose, Postprandial

Intervention

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

Locations

Country	Name	City	State
Canada	Canadian Center for Functional Medicine	Coquitlam	British Columbia
Canada	Canadian Centre for Functional Medicine	Coquitlam	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Center for Functional Medicine	InovoBiologic Inc., University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Kacinik V, Lyon M, Purnama M, Reimer RA, Gahler R, Green TJ, Wood S. Effect of PGX, a novel functional fibre supplement, on subjective ratings of appetite in overweight and obese women consuming a 3-day structured, low-calorie diet. Nutr Diabetes. 2011 De — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.		3 days	No
Secondary	Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles.		3 days	No