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

January 19, 2023 updated by: University of Manitoba
To describe the effect and mechanisms of action faba bean powder and fractions (protein, starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic regulation in young adults (18 to 30 years).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The overall objective is to describe the effect and mechanisms of action of faba bean powder and fractions (protein, starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic regulation in young adults (18 to 30 years). The specific objectives are to test the acute effects of different faba bean ingredient smoothie on: 1) post-prandial blood glucose, appetite, satiety hormone and insulin for 200 minutes, and 2) food intake 120 minutes following consumption of the faba bean smoothie. Two short-term acute studies will be conducted to meet these objectives. Both acute studies will follow a randomized, double blinded, balanced, repeated measures design and the same protocol; except one will have an ad libitum pizza meal (study 1), while the other will have a fixed pizza meal (study 2) at 120 minutes. Half the participants will have blood drawn by IV and the other half will be finger prick.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • Richardson Centre for Functional Foods and Nutraceuticals

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy
  • non-smoking males
  • aged 20-30 years (min/max age)
  • a body mass index between 20 and 25 kg/m2 (the range generally accepted as ideal/healthy by Health and Welfare Canada)

Exclusion Criteria:

  • individuals diagnosed with diabetes
  • those on medication
  • breakfast skippers
  • on an energy restricted diet
  • this study excludes females because appetite and blood glucose during the female menstruation cycle changes due to fluctuations in hormones

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control smoothie
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
Other: Faba bean powder smoothie
Breakfast smoothie with 32 g whole faba bean powder (300g).
Other: Faba bean protein concentrate smoothie
Breakfast smoothie with 32 g faba bean protein concentrate.
Other: Faba bean starch smoothie
Breakfast smoothie with 33 g faba bean starch.
Other: Faba bean protein isolate smoothie
Breakfast smoothie with 32 g faba bean protein isolate.
Experimental: Faba Bean powder smoothie
Breakfast smoothie with 32 g whole faba bean powder.
Other: Faba bean protein concentrate smoothie
Breakfast smoothie with 32 g faba bean protein concentrate.
Other: Faba bean starch smoothie
Breakfast smoothie with 33 g faba bean starch.
Other: Faba bean protein isolate smoothie
Breakfast smoothie with 32 g faba bean protein isolate.
Other: Non-pulse smoothie smoothie
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
Experimental: Faba bean protein concentrate smoothie
Breakfast smoothie with 32 g faba bean protein concentrate.
Other: Faba bean powder smoothie
Breakfast smoothie with 32 g whole faba bean powder (300g).
Other: Faba bean starch smoothie
Breakfast smoothie with 33 g faba bean starch.
Other: Faba bean protein isolate smoothie
Breakfast smoothie with 32 g faba bean protein isolate.
Other: Non-pulse smoothie smoothie
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
Experimental: Faba bean starch smoothie
Breakfast smoothie with 33 g faba bean starch.
Other: Faba bean powder smoothie
Breakfast smoothie with 32 g whole faba bean powder (300g).
Other: Faba bean protein concentrate smoothie
Breakfast smoothie with 32 g faba bean protein concentrate.
Other: Faba bean protein isolate smoothie
Breakfast smoothie with 32 g faba bean protein isolate.
Other: Non-pulse smoothie smoothie
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
Experimental: Faba bean protein isolate smoothie
Breakfast smoothie with 32 g faba bean protein isolate.
Other: Faba bean powder smoothie
Breakfast smoothie with 32 g whole faba bean powder (300g).
Other: Faba bean protein concentrate smoothie
Breakfast smoothie with 32 g faba bean protein concentrate.
Other: Faba bean starch smoothie
Breakfast smoothie with 33 g faba bean starch.
Other: Non-pulse smoothie smoothie
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
blood glucose
Time Frame: 0-200 minutes
measured by finger prick blood samples by glucose meters
0-200 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
appetite
Time Frame: 0-200 minutes
measured by VAS questionnaire
0-200 minutes
satiety hormones
Time Frame: 0- 200mins
measured by enzyme-linked immunosorbent assay (ELISA)
0- 200mins
insulin
Time Frame: 0-200mins
measured by ELISA
0-200mins
food intake
Time Frame: 120 minutes following consumption of the faba bean smoothie
energy intake at ad-libitum pizza meal
120 minutes following consumption of the faba bean smoothie
physical comfort
Time Frame: 0-200 minutes
measured by VAS questionnaire
0-200 minutes
energy/fatigue
Time Frame: 0-200 minutes
measured by VAS questionaire
0-200 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2015:110

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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