NCT01387126
Withdrawn
Phase 3
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
Canadian Center for Functional Medicine1 site in 1 countryJuly 4, 2011
ConditionsObesity
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Canadian Center for Functional Medicine
- Locations
- 1
- Primary Endpoint
- Body weight
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Body weight
Time Frame: 52 weeks
Secondary Outcomes
- Body composition(52 weeks)
Study Sites (1)
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