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

NCT ID: NCT01109199

Last Updated: 2015-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Appetite Suppression Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PolyGlycopleX (PGX)

Group Type EXPERIMENTAL

PolyGlycopleX (PGX)

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Rice flour

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

InovoBiologic Inc.

INDUSTRY

Sponsor Role collaborator

Canadian Center for Functional Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael R Lyon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Canadian Center for Functional Medicine

Locations

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Canadian Center for Functional Medicine

Coquitlam, British Columbia, Canada

Site Status

Canadian Center for Functional Medicine

Coquitlam, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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PGX RCT Study

Identifier Type: -

Identifier Source: org_study_id

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