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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Canadian Center for Functional Medicine
Sponsor:
Collaborators:
University of British Columbia
InovoBiologic Inc.
Information provided by (Responsible Party):
Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier:
NCT01387126
First received: June 30, 2011
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Dietary Supplement: Novel fibre supplement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Canadian Center for Functional Medicine:

Primary Outcome Measures:
  • Body weight [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: January 2013
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387126

Contacts
Contact: Monica Purnama, MSc 604-777-5500

Locations
Canada, British Columbia
Canadian Centre for Functional Medicine Not yet recruiting
Coquitlam, British Columbia, Canada, V7L1B5
Contact: Veronica Kacinik, MSc, RD       info@functionalmedicine.ca   
Sponsors and Collaborators
Canadian Center for Functional Medicine
University of British Columbia
InovoBiologic Inc.
Investigators
Principal Investigator: Michael R Lyon, MD Canadian Centre for Functional Medicine
  More Information

No publications provided

Responsible Party: Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier: NCT01387126     History of Changes
Other Study ID Numbers: 004
Study First Received: June 30, 2011
Last Updated: November 15, 2012
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on October 19, 2014