NCT02366572

Brief Summary

The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products. We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse cereals.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 23, 2023

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

December 17, 2014

Last Update Submit

January 19, 2023

Conditions

Diabetes PreventionObesity Prevention

Outcome Measures

Primary Outcomes (3)

  • Plasma Glucose and Insulin Concentrations

    Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits

    0 - 200 min

  • Food Intake

    Measured by VAS questionnaire

    at 120 min

  • Subjective Appetite

    Motivation-to-eat VAS questionnaire

    0-200 min

Secondary Outcomes (3)

  • Palatability of treaments and meal

    5 and 140 minutes

  • Physical comfort

    0 - 200 min

  • Energy/fatigue

    0-200 min

Study Arms (6)

Cereal control

PLACEBO COMPARATOR

100% Wheat Flour

Other: Control

Cereal with pea protein

EXPERIMENTAL

Pea protein

Other: Pea protein

Cereal with pea starch

EXPERIMENTAL

Pea starch

Other: Pea starch

Cereal w/ pea starch + pea fibre: 5g

EXPERIMENTAL

Pea starch + pea fibre: 5g

Other: Pea fibre + pea starch

Cereal w/ pea protein + pea starch: 10g

EXPERIMENTAL

Pea protein + pea starch: 10g

Other: Pea protein + pea starch

Cereal w/ pea protein + pea fibre + pea starch: 20g

EXPERIMENTAL

Pea protein + pea fibre + pea starch: 20g

Other: Pea fibre + pea starch + pea protein

Interventions

ControlOTHER

Non pulse extruded cereal

Cereal control
Pea proteinOTHER

Pulse extruded cereal

Cereal with pea protein
Pea starchOTHER

Pulse extruded cereal

Cereal with pea starch
Pea fibre + pea starchOTHER

Pulse extruded cereal

Cereal w/ pea starch + pea fibre: 5g
Pea protein + pea starchOTHER

Pulse extruded cereal

Cereal w/ pea protein + pea starch: 10g
Pea fibre + pea starch + pea proteinOTHER

Pulse extruded cereal

Cereal w/ pea protein + pea fibre + pea starch: 20g

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normoglycemic (\<5.6 mmol/L) and normotensive (systolic blood pressure \<140 mm Hg and diastolic blood pressure below \< 90 mm Hg)
  • BMI of 18.5-29.9 kg/m2

You may not qualify if:

  • Restrained eaters
  • Regularly skip breakfast
  • Smokers
  • Competitive sports or athletic training at a high intensity
  • Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
  • Those unable to walk for an hour continuously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Johnston AJ, Mollard RC, Dandeneau D, MacKay DS, Ames N, Curran J, Bouchard DR, Jones PJ. Acute effects of extruded pea fractions on glycemic response, insulin, appetite, and food intake in healthy young adults, results of a double-blind, randomized crossover trial. Appl Physiol Nutr Metab. 2021 Sep;46(9):1126-1132. doi: 10.1139/apnm-2020-0571. Epub 2021 Mar 4.

    PMID: 33661714DERIVED

MeSH Terms

Interventions

Pea Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Peter JH Jones, PhD

    University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

February 19, 2015

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

January 23, 2023

Record last verified: 2021-04