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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01387126
• Other study ID #: 004
• Status: Withdrawn
• Phase: Phase 3

Study information

• Verified date: July 2017
• Source: Canadian Center for Functional Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Novel fibre supplement
The full dose of the study intervention is 15 grams per day.

Locations

Country	Name	City	State
Canada	Canadian Centre for Functional Medicine	Coquitlam	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Center for Functional Medicine	InovoBiologic Inc., University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		52 weeks
Secondary	Body composition		52 weeks