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

NCT ID: NCT01387126

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Novel fibre supplement

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

Group Type EXPERIMENTAL

Novel fibre supplement

Intervention Type DIETARY_SUPPLEMENT

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

Weight management program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Novel fibre supplement

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

InovoBiologic Inc.

INDUSTRY

Sponsor Role collaborator

Canadian Center for Functional Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael R Lyon, MD

Role: PRINCIPAL_INVESTIGATOR

Canadian Centre for Functional Medicine

Locations

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Canadian Centre for Functional Medicine

Coquitlam, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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004

Identifier Type: -

Identifier Source: org_study_id

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