Effects of a Dietary Fibre Supplementation of a Low Calor... | NCT01109199

Studies
Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight

NCT01109199

Sponsor

Canadian Center for Functional Medicine

Status

Completed

Last Update Posted

Oct 2, 2015Estimated

Enrollment

20Actual

Phase

Phase 3

Conditions

Appetite Suppression
Weight Loss

Interventions

PolyGlycopleX (PGX)
Rice flour

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Apr 20, 2010

First Submission Date that Met QC Criteria

Apr 22, 2010

First Posted Date

Apr 23, 2010Estimated

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

Sep 30, 2015

Last Update Posted Date

Oct 2, 2015Estimated

Name	Class
University of British Columbia	OTHER
InovoBiologic Inc.	INDUSTRY

Description Module

Brief Summary

This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female.

The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a 14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the rice flour supplementation of the LCD.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PolyGlycopleX (PGX)	Experimental		Dietary Supplement: PolyGlycopleX (PGX)
Rice Flour	Placebo Comparator		Dietary Supplement: Rice flour

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PolyGlycopleX (PGX)	Dietary Supplement	The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.	PolyGlycopleX (PGX)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference in appetite score assessed from appetite Visual Analog Scale		18 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in weight (kilograms)		18 weeks
Change in percentage of body fat		18 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 25 - 35 Kg/m2

Exclusion Criteria:

Medications and supplements that affect appetite
Known diabetes
Contraindications to LCD
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

Yes

Sex

Female

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, M.D.	Canadian Center for Functional Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Canadian Center for Functional Medicine		Coquitlam	British Columbia	V3K 6Y7	Canada
Canadian Center for Functional Medicine

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C540519	PolyGlycoplex
D005433	Flour

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided