NCT02402504

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.4 years 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

1.3 years

First QC Date

December 20, 2014

Last Update Submit

January 19, 2023

Conditions

Diabetes PreventionObesity Prevention

Outcome Measures

Primary Outcomes (3)

  • Plasma Glucose and Insulin Concentrations

    Measured in blood using intravenous catheter at 12 time points and used to calculate area under curve (AUC). Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits (Composite measure)

    0 - 200 min

  • Food Intake

    Ad-libitum meal

    at 120 min

  • Subjective Appetite

    Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure)

    0-200 min

Secondary Outcomes (4)

  • Palatability of treatments

    at 5 minutes

  • Palatability of meal

    at 140 minutes

  • Energy and Fatigue

    0-200 min

  • Physical Comfort

    0-200 min

Study Arms (6)

Extruded snack control

PLACEBO COMPARATOR

100% corn flour

Other: Control

Extruded snack with small particle size pea flour

EXPERIMENTAL

60% corn flour and 40% small particle size pea flour

Other: Small particle size pea flour

Extruded snack with large particle size pea flour

EXPERIMENTAL

60% corn flour and 40% large particle size pea flour

Other: Large particle size pea flour

Extruded snack with lentil flour

EXPERIMENTAL

60% corn flour and 40% lentil flour

Other: Lentil flour

Extruded snack navy bean flour

EXPERIMENTAL

60% corn flour and 40% navy bean flour

Other: Navy bean flour

Extruded snack with pinto bean flour

EXPERIMENTAL

60% corn flour and 40% pinto bean flour

Other: Pinto bean flour

Interventions

ControlOTHER

Non pulse extruded snack

Extruded snack control
Small particle size pea flourOTHER

Pulse extruded snack

Extruded snack with small particle size pea flour
Large particle size pea flourOTHER

Pulse extruded snack

Extruded snack with large particle size pea flour
Lentil flourOTHER

Pulse extruded snack

Extruded snack with lentil flour
Navy bean flourOTHER

Pulse extruded snack

Extruded snack navy bean flour
Pinto bean flourOTHER

Pulse extruded snack

Extruded snack with pinto bean flour

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • Johnston AJ, Mollard RC, Dandeneau D, MacKay DS, Ames N, Curran J, Bouchard DR, Jones PJ. Acute effects of extruded pulse snacks on glycemic response, insulin, appetite, and food intake in healthy young adults in a double blind, randomized, crossover trial. Appl Physiol Nutr Metab. 2021 Jul;46(7):704-710. doi: 10.1139/apnm-2020-0572. Epub 2020 Dec 21.

    PMID: 33347383DERIVED

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, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2014

First Posted

March 30, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2016

Study Completion

December 1, 2017

Last Updated

January 23, 2023

Record last verified: 2021-04

Locations

CA(1)