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OpenTrials
Completed

NCT Number: NCT01109199

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

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.

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Key information

Conditions

Appetite Suppression Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Canadian Center for Functional Medicine, Coquitlam, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PolyGlycopleX (PGX)

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. The difference in appetite score assessed from appetite Visual Analog Scale

    Time frame: 18 weeks

Secondary outcomes

  1. Change in weight (kilograms)

    Time frame: 18 weeks

  2. Change in percentage of body fat

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

Canadian Center for Functional Medicine

Other

Collaborators

  • InovoBiologic Inc.
  • University of British Columbia

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 23, 2010
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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