Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNovel fibre supplement
The full dose of the study intervention is 15 grams per day.
Sponsors
University of British Columbia
InovoBiologic Inc.
Canadian Center for Functional Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Body composition | 52 weeks |
Countries
Canada
Outcome results
None listed