NCT02015429

Brief Summary

The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2007

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 active sites

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

December 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

December 9, 2013

Last Update Submit

December 12, 2013

Conditions

Keywords

Food intakesatietyglycemiaappetiteblood glucoseyellow peasfibreproteinmixed meal

Outcome Measures

Primary Outcomes (2)

  • Ad libitum food intake at second pizza meal

    Food intake measured via electronic scale in g, then converted to kcal using the caloric density.

    135 mins after completion of treatment, 20 mins to eat pizza meal.

  • Blood glucose

    Blood glucose measured via hand-held glucometer and finger prick.

    between 0 and 215 mins, every 15-30 mins

Secondary Outcomes (1)

  • Subjective appetite

    0 to 215 minutes

Other Outcomes (1)

  • Palatability of treatments

    following treatment consumption at 15 mins

Study Arms (4)

Control

ACTIVE COMPARATOR

Pasta meal with added fractions or control with no fractions Pasta meal with no pea fractions

Dietary Supplement: Pasta meal with added fractions or control with no fractions

10 g protein

EXPERIMENTAL

Pasta meal with added fractions or control with no fractions 10 g net yellow pea protein added to pasta meal

Dietary Supplement: Pasta meal with added fractions or control with no fractions

7 g yellow pea fibre

EXPERIMENTAL

Pasta meal with added fractions or control with no fractions 7 g net yellow pea fibre added to pasta meal

Dietary Supplement: Pasta meal with added fractions or control with no fractions

Yellow pea fibre & protein

EXPERIMENTAL

Pasta meal with added fractions or control with no fractions 10 g net yellow pea protein plus 7 g net yellow pea fibre added to pasta meal

Dietary Supplement: Pasta meal with added fractions or control with no fractions

Interventions

10 g protein7 g yellow pea fibreControlYellow pea fibre & protein

Eligibility Criteria

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

You may qualify if:

  • Non-smoking
  • No metabolic disease
  • BMI 20 - 25 kg/m\^2
  • male
  • age 20-30

You may not qualify if:

  • Intolerance to treatments
  • on appetite-modifying medications
  • restrictive eating
  • smoking
  • over or underweight
  • breakfast-skipping

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Toronto - Department of Nutritional Sciences

Toronto, Ontario, M5S 3E2, Canada

Location

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Harvey G Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 19, 2013

Study Start

December 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 19, 2013

Record last verified: 2013-12

Locations