Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight

Sponsor

Canadian Center for Functional Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01109199

Collaborator

University of British Columbia (Other), InovoBiologic Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female.

The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a 14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the rice flour supplementation of the LCD.

Condition or Disease	Intervention/Treatment	Phase
Appetite Suppression Weight Loss	Dietary Supplement: PolyGlycopleX (PGX) Dietary Supplement: Rice flour	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre (PGX) Supplementation of a Low Calorie Diet on Appetite and Body Weight, in Overweight and Moderately Obese Females

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PolyGlycopleX (PGX)	Dietary Supplement: PolyGlycopleX (PGX) The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
Placebo Comparator: Rice Flour	Dietary Supplement: Rice flour The full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.

Arm

Intervention/Treatment

Experimental: PolyGlycopleX (PGX)

Dietary Supplement: PolyGlycopleX (PGX)

The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.

Placebo Comparator: Rice Flour

Dietary Supplement: Rice flour

The full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.

Outcome Measures

Primary Outcome Measures

The difference in appetite score assessed from appetite Visual Analog Scale [18 weeks]

Secondary Outcome Measures

Change in weight (kilograms) [18 weeks]
Change in percentage of body fat [18 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI 25 - 35 Kg/m2

Exclusion Criteria:

Medications and supplements that affect appetite
Known diabetes
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.