Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program

July 29, 2019 updated by: Canadian Center for Functional Medicine

A Randomized, Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program, on Body Weight in Overweight and Obese Individuals

The aim of this study is to investigate whether the supplementation of a medically supervised weight management program with a novel fibre supplement, improves body weight, body composition, and laboratory measurements in overweight and obese individuals. All subjects will participate in the medical weight management program however the intervention group will have 5 grams of a novel fibre supplemented to each meal while the control group will not.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V7L1B5
        • Canadian Centre for Functional Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 27 - 30 Kg/m2 with 1 weight-related comorbidity and/or BMI 30 - 50 Kg/m2
  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation in English

Exclusion Criteria:

  • Medications and supplements that affect body weight and appetite
  • Type 2 diabetes on insulin treatment
  • Contraindications to low calorie diet
  • Any allergies to study product ingredients
  • Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novel fibre supplement
The full dose of the study intervention is 15 grams per day.
Dietary supplement: Novel fibre supplement
The full dose of the study intervention is 15 grams per day.
No Intervention: Weight management program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Center for Functional Medicine

Collaborators

University of British Columbia
InovoBiologic Inc.

Investigators

  • Principal Investigator: Michael R Lyon, MD, Canadian Centre for Functional Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 30, 2011

First Submitted That Met QC Criteria

July 1, 2011

First Posted (Estimate)

July 4, 2011

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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