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NCT01109199 Clinical Trial

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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01109199
Other study ID # PGX RCT Study
Secondary ID
Status Completed
Phase Phase 3
First received April 20, 2010
Last updated September 30, 2015
Start date August 2010
Est. completion date April 2011

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 55 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

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.
• 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.

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

Outcome
Type Measure Description Time frame Safety issue
Primary The difference in appetite score assessed from appetite Visual Analog Scale 18 weeks No
Secondary Change in weight (kilograms) 18 weeks No
Secondary Change in percentage of body fat 18 weeks No
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