Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control

June 23, 2023 updated by: G. Harvey Anderson, University of Toronto
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 3E2
        • University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Non-smoking
  • No metabolic disease
  • BMI 20 - 25 kg/m^2
  • Male
  • Age 18-30

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Crackers/pasta with no faba bean fraction
Dietary supplement: Crackers/pasta with no faba bean fraction
Control treatment
Experimental: Faba bean protein concentrate
Crackers/pasta with added faba bean protein concentrate
Dietary supplement: Crackers/pasta with added faba bean protein concentrate
Protein concentrate treatment
Experimental: Faba bean protein isolate
Crackers/pasta with added faba bean protein isolate
Dietary supplement: Crackers/pasta with added faba bean protein isolate
Protein isolate treatment
Experimental: Faba bean flour
Crackers/pasta with added faba bean flour
Dietary supplement: Crackers/pasta with added faba bean flour
Flour treatment
Experimental: Faba bean starch
Crackers/pasta with added faba bean starch
Dietary supplement: Crackers/pasta with added faba bean starch
Starch treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood glucose levels
Time Frame: 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)
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
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective appetite
Time Frame: From 0 to 200 minutes
Measured using Visual Analog Scales (VAS)
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
Time Frame: 120 minutes after completion of treatment, 20 minutes were allocated to allow for pizza consumption
Each participant will also answer questions related to physical comfort, motivation to eat, and rating feelings of energy and fatigue using Visual Analog Scales (VAS)
120 minutes after completion of treatment, 20 minutes were allocated to allow for pizza consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Harvey G Anderson, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimated)

January 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SPG_UofT_FabaBean

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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