Effects of a High Viscosity Dietary Fibre, as Part of a M... | NCT01387126

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

NCT01387126

Sponsor

Canadian Center for Functional Medicine

Status

Withdrawn

Last Update Posted

Jul 31, 2019Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Obesity

Interventions

Novel fibre supplement

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No grant funding for this trial.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 30, 2011

First Submission Date that Met QC Criteria

Jul 1, 2011

First Posted Date

Jul 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2019

Last Update Posted Date

Jul 31, 2019Actual

Name	Class
University of British Columbia	OTHER
InovoBiologic Inc.	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Novel fibre supplement	Dietary Supplement	The full dose of the study intervention is 15 grams per day.	Novel fibre supplement

Measure	Description	Time Frame
Body weight		52 weeks

Measure	Description	Time Frame
Body composition		52 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael R Lyon, MD	Canadian Centre for Functional Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Canadian Centre for Functional Medicine		Coquitlam	British Columbia	V7L1B5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided