NCT02385890

Brief Summary

The objectives are to test the acute effects of different bagels 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. The investigators hypothesize that bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.

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 Oct 2016

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

First Submitted

Initial submission to the registry

December 17, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2018

Completed
Last Updated

January 23, 2023

Status Verified

April 1, 2021

Enrollment Period

1.3 years

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

    Measured in blood using intravenous catheter at 12 time points 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

    0-200

  • Food Intake

    Ad-libitum meal. Food consumed measured by weight

    at 120 min

  • Subjective Appetite

    Motivation-to-eat VAS questionnaire used to calculate area under curve (AUC)

    0-200 min

Secondary Outcomes (4)

  • Palatability of meal

    at 140 mins

  • Palatability of treatments

    at 5 mins

  • Physical comfort

    0 - 200 min

  • Energy/fatigue measured by VAS questionnaire

    0 - 200 mins

Study Arms (6)

Bagel control

EXPERIMENTAL

100% wheat flour

Other: Control

Bagel with pea flour

EXPERIMENTAL

Pea flour

Other: Pea flour

Bagel with pea fibre

EXPERIMENTAL

Pea fibre

Other: Pea fibre

Bagel with pea protein

EXPERIMENTAL

Pea protein

Other: Pea protein

Bagel with pea flour + pea protein

EXPERIMENTAL

Pea flour + pea protein

Other: Pea flour + pea protein

Bagel with pea fibre + pea protein

EXPERIMENTAL

Pea fibre + pea protein

Other: Pea fibre + pea protein

Interventions

ControlOTHER

Non pulse ingredient bagel

Bagel control
Pea flourOTHER

Pulse ingredient bagel

Bagel with pea flour
Pea fibreOTHER

Pulse ingredient bagel

Bagel with pea fibre
Pea proteinOTHER

Pulse ingredient bagel

Bagel with pea protein
Pea flour + pea proteinOTHER

Pulse ingredient bagel

Bagel with pea flour + pea protein
Pea fibre + pea proteinOTHER

Pulse ingredient bagel

Bagel with pea fibre + pea protein

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 who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
  • 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

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

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

Study Record Dates

First Submitted

December 17, 2014

First Posted

March 11, 2015

Study Start

October 1, 2016

Primary Completion

January 14, 2018

Study Completion

January 14, 2018

Last Updated

January 23, 2023

Record last verified: 2021-04

Locations

CA(1)