NCT02658591

Brief Summary

The investigators hypothesized that consuming crackers or pasta enriched with faba bean fractions (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean starch), would reduce the blood glucose response to the meal compared to foods without faba bean components and reduce food intake at a meal

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

8 years

First QC Date

January 11, 2016

Last Update Submit

June 23, 2023

Conditions

ObesityDiabetes

Keywords

Food intakeSatietyAppetiteGlycemiaFaba beanProteinSnack

Outcome Measures

Primary Outcomes (2)

  • Change in blood glucose levels

    Each participant will attend 5 sessions in total (randomized 5-arm cross-over design)

    Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 200 minutes (time of completion of each session)

  • Change in gut hormone levels measured in the blood

    Each participant will attend 5 sessions in total (randomized 5-arm cross-over design)

    Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 30 minutes up to 200 minutes (time of completion of each session)

Secondary Outcomes (2)

  • Subjective appetite

    From 0 to 200 minutes

  • Ad libitum food (pizza meal) intake as measured by the amount of pizza (in grams) consumed during the 20 minute period

    120 minutes after completion of treatment, 20 minutes were allocated to allow for pizza consumption

Study Arms (5)

Control

ACTIVE COMPARATOR

Crackers/pasta with no faba bean fraction

Dietary Supplement: Crackers/pasta with no faba bean fraction

Faba bean protein concentrate

EXPERIMENTAL

Crackers/pasta with added faba bean protein concentrate

Dietary Supplement: Crackers/pasta with added faba bean protein concentrate

Faba bean protein isolate

EXPERIMENTAL

Crackers/pasta with added faba bean protein isolate

Dietary Supplement: Crackers/pasta with added faba bean protein isolate

Faba bean flour

EXPERIMENTAL

Crackers/pasta with added faba bean flour

Dietary Supplement: Crackers/pasta with added faba bean flour

Faba bean starch

EXPERIMENTAL

Crackers/pasta with added faba bean starch

Dietary Supplement: Crackers/pasta with added faba bean starch

Interventions

Crackers/pasta with added faba bean protein concentrateDIETARY_SUPPLEMENT

Protein concentrate treatment

Faba bean protein concentrate
Crackers/pasta with added faba bean protein isolateDIETARY_SUPPLEMENT

Protein isolate treatment

Faba bean protein isolate
Crackers/pasta with added faba bean starchDIETARY_SUPPLEMENT

Starch treatment

Faba bean starch
Crackers/pasta with added faba bean flourDIETARY_SUPPLEMENT

Flour treatment

Faba bean flour
Crackers/pasta with no faba bean fractionDIETARY_SUPPLEMENT

Control treatment

Control

Eligibility Criteria

Age18 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 18-30

You may not qualify if:

  • Intolerance to treatments
  • Currently taking appetite-modifying medications
  • Restrictive eating
  • Smoking
  • Over- or underweight
  • Breakfast-skipping

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (1)

  • Chan CKY, Fabek H, Mollard RC, Jones PJH, Tulbek MC, Chibbar RN, Gangola MP, Ramadoss BR, Sanchez-Hernandez D, Anderson GH. Faba bean protein flours added to pasta reduce post-ingestion glycaemia, and increase satiety, protein content and quality. Food Funct. 2019 Nov 1;10(11):7476-7488. doi: 10.1039/c9fo01186b. Epub 2019 Oct 31.

    PMID: 31670336DERIVED

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

January 11, 2016

First Posted

January 20, 2016

Study Start

January 1, 2016

Primary Completion

December 31, 2023

Study Completion

May 31, 2024

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

CA(1)