Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program
Phase 3
Withdrawn
- Conditions
- Obesity
- Registration Number
- NCT01387126
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Body weight 52 weeks
- Secondary Outcome Measures
Name Time Method Body composition 52 weeks
Trial Locations
- Locations (1)
Canadian Centre for Functional Medicine
🇨🇦Coquitlam, British Columbia, Canada
Canadian Centre for Functional Medicine🇨🇦Coquitlam, British Columbia, Canada