Yellow Pea Fractions and Short-term Food Intake, Subjecti... | NCT01242059

Studies
Yellow Pea Fractions and Short-term Food Intake, Subjective Appetite and Glycemic Response

NCT01242059

Sponsor

University of Toronto

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Obesity
Type II Diabetes Mellitus
Metabolic Syndrome

Interventions

yellow pea protein
yellow pea fiber
Control

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

Jun 2012

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

Jan 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 12, 2010

First Submission Date that Met QC Criteria

Nov 12, 2010

First Posted Date

Nov 16, 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

Jun 13, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Name	Class
Agriculture and Agri-Food Canada	OTHER_GOV
Pulse Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.

Detailed Description

A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 2 hours after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Control Tomato Soup	Experimental	Dietary Supplement: Control
10 g of yellow pea fiber	Experimental	Other: yellow pea fiber
20 g of yellow pea fiber	Experimental	Other: yellow pea fiber
10 g of yellow pea protein	Experimental	Dietary Supplement: yellow pea protein
20 g of yellow pea protein	Experimental	Dietary Supplement: yellow pea protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
yellow pea protein	Dietary Supplement	Served in a tomato soup	10 g of yellow pea protein 20 g of yellow pea protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Energy Intake	Energy intake at an ad libitum pizza meal	at 120 minutes after treatment

Secondary Outcomes

Measure	Description	Time Frame
Glycemic Response		200 minutes
Subjective Appetite		200 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male 20-30 years old healthy weight

Exclusion Criteria:

smoking restrictive eating metabolic diseases breakfast skippers dieters

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

29 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
G Harvey Anderson, Ph.D	University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Toronto - Department of Nutritional Sciences		Toronto	Ontario	M5S 3E2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2
D024821	Metabolic Syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided