- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01387126
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Withdrawn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
-
-
British Columbia
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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.
|
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.
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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