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

NCT01387126 | Withdrawn Phase 3

• 1 other identifier: 004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Body weight

  52 weeks

Secondary Outcomes (1)

• Body composition

  52 weeks

Study Arms (2)

Novel fibre supplement

EXPERIMENTAL

The full dose of the study intervention is 15 grams per day.

Dietary Supplement: Novel fibre supplement

Weight management program

NO INTERVENTION

Interventions

Novel fibre supplement DIETARY_SUPPLEMENT

The full dose of the study intervention is 15 grams per day.

Novel fibre supplement

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Center for Functional Medicine: lead
• University of British Columbia: collaborator
• InovoBiologic Inc.: collaborator

Study Sites (1)

Canadian Centre for Functional Medicine

Coquitlam, British Columbia, V7L1B5, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael R Lyon, MD

  Canadian Centre for Functional Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 4, 2011
• Last Updated: July 31, 2019

Record last verified: 2017-07

Locations

CA (1)