NCT01298154

Brief Summary

The purpose of this protocol is to study the effects of intact and hydrolyzed yellow pea protein, compared to intact and hydrolyzed whey protein, on satiety, food intake, and glucose metabolism in healthy young men. The specific objective is to investigate the effects of 20 g available protein for 4 different protein types (intact and hydrolyzed pea and whey proteins) and water (control) on satiety, food intake and blood glucose before and after a meal. The specified amount of protein was chosen based on our previous studies on intact pea protein suggesting that 20 g may reduce food intake and pre-meal blood glucose 30 minutes before a test meal. Whey protein has been chosen as a reference protein because it has been extensively studied and its effects on blood glucose and food intake are being elucidated within our laboratory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
Last Updated

May 5, 2011

Status Verified

February 1, 2011

Enrollment Period

1.4 years

First QC Date

April 14, 2010

Last Update Submit

May 4, 2011

Conditions

Diabetes PreventionObesity Prevention

Keywords

Food intakeBlood glucosePulsesProtein

Outcome Measures

Primary Outcomes (1)

  • Food Intake

    30 minutes

Secondary Outcomes (1)

  • Blood Glucose

    0, 15, 30, 50, 65, 80, 95, 110, 140 and 170 minutes

Study Arms (5)

Intact Pea Protein (20 g)

EXPERIMENTAL
Other: Dietary intervention

Hydrolyzed Pea Protein (20 g)

EXPERIMENTAL
Other: Dietary intervention

Intact Whey Protein

EXPERIMENTAL
Other: Dietary intervention

Hydrolyzed Whey Protein

EXPERIMENTAL
Other: Dietary intervention

Water

EXPERIMENTAL
Other: Dietary intervention

Interventions

Dietary interventionOTHER

Dietary treatments with beverages

Hydrolyzed Pea Protein (20 g)Hydrolyzed Whey ProteinIntact Pea Protein (20 g)Intact Whey ProteinWater

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Non-smoking
  • Aged 20-30 years
  • Body mass index between 20 and 24.9 kg/m2

You may not qualify if:

  • Diabetes
  • Gastrointestinal conditions
  • Medication
  • Lactose-intolerance or allergies to milk (standard breakfast provided)
  • Breakfast skippers and those on an energy restricted diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Harvey Anderson, PHD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2010

First Posted

February 17, 2011

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

May 5, 2011

Record last verified: 2011-02

Locations

CA(1)