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

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ClinicalTrials.gov Identifier: NCT01387126
Recruitment Status : Suspended (No grant funding yet for this trial.)
First Posted : July 4, 2011
Last Update Posted : July 19, 2017
Sponsor:
Collaborators:
University of British Columbia
InovoBiologic Inc.
Information provided by (Responsible Party):
Canadian Center for Functional Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Dietary Supplement: Novel fibre supplement Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Body weight [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Body composition [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387126


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

Responsible Party: Canadian Center for Functional Medicine
ClinicalTrials.gov Identifier: NCT01387126     History of Changes
Other Study ID Numbers: 004
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017