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

Phase 3

Completed

• Conditions: Appetite and Hunger, Suppression; Blood Glucose, Postprandial
• Interventions: Dietary Supplement: PolyGlycopleX (PGX)

• Registration Number: NCT01108328
• Lead Sponsor: Canadian Center for Functional Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-22
• Study Start: 2010-06
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rice flour	PolyGlycopleX (PGX)	5 grams of rice flour 3 times per day at each main meal (breakfast, lunch and dinner)
PolyGlycopleX (PGX)	PolyGlycopleX (PGX)	5 grams of PGX 3 times per day with each main meal (breakfast, lunch and dinner)

Primary Outcome Measures

Name	Time	Method
Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.	3 days

Secondary Outcome Measures

Name	Time	Method
Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles.	3 days

Trial Locations

Locations (2)

Canadian Centre for Functional Medicine; 🇨🇦 Coquitlam, British Columbia, Canada

Canadian Center for Functional Medicine; 🇨🇦 Coquitlam, British Columbia, Canada