Glycemic Responses and Sensory Characteristics of Whole Yellow Pea Flour Added to Novel Functional Foods

April 7, 2009 updated by: University of Manitoba
The objective of this study was to determine if whole yellow pea flour reduces post-prandial glycemic responses of novel food products. The second objective was to determine if whole yellow pea flour produces food products with favorable sensory characteristics including appearance, taste, smell, texture and overall acceptability, compared to corresponding food products made with whole wheat flour.

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

Pulses, including yellow peas, are readily available and low-cost commodities that are gaining considerable momentum as functional ingredients possessing health benefits, as these food materials are high in fiber, protein, antioxidants, and low in fat. As incidence rates of type II diabetes continue to climb, new novel ingredients that produce low-glycemic food products are in demand. Consumption of whole pulses have been shown to lower post-prandial glycemic responses (Jenkins and others 1983), however, their addition to foods often produces unfavorable sensory characteristics. To date, few studies have examined the feasibility of producing food products containing pulse-derived ingredients that reduce post-prandial glycemic responses, lower glycemic indexes (GI) and at the same time possess sensory qualities that appeal to consumers. Since yellow peas are readily available and relatively inexpensive, they are a promising candidate for use as novel ingredients for the development of low-glycemic, consumer-friendly functional foods.

The objective of the present study was to first determine the post-prandial glycemic response and GI of novel foods containing whole yellow pea flour (WYPF) as a functional ingredient. The second objective was to determine the acceptability of sensory characteristics for each WYPF food product.

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.
23

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.
  • Phase 2

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy men
  • non-lactating women
  • BMI's between 18 and 31 kg/m2

Exclusion Criteria:

  • heart disease
  • diabetes
  • thyroid disease
  • celiac disease
  • gluten intolerance
  • taking corticosteroid medications
  • smokers
  • Chronic alcohol usage (> 2 drinks/d)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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: Whole wheat banana bread
Banana bread made with whole wheat flour
Dietary supplement: Whole wheat banana bread

Dose was portioned so that subjects received 50 g available carbohydrate

Portion: 62.8 g Available CHO: 51.7 g
Active Comparator: Whole pea flour banana bread
Banana bread made with whole pea flour
Dietary supplement: Whole pea flour banana bread

Dose was portioned so that subjects received 50 g available carbohydrate

Portion: 67.8 g Available CHO: 52.0 g
Placebo Comparator: Whole wheat biscotti
Biscotti made with whole wheat flour
Dietary supplement: Whole wheat biscotti

Dose was portioned so that subjects received 50 g available carbohydrate

Portion: 79.8 g Available CHO: 53.1 g
Active Comparator: Whole pea biscotti
Biscotti made with whole pea flour
Dietary supplement: Whole pea flour biscotti

Dose was portioned so that subjects received 50 g available carbohydrate

Portion: 86 g Available CHO: 51.7 g
Placebo Comparator: Whole wheat pasta
Pasta made with whole wheat durum
Dietary supplement: Whole wheat pasta

Dose was portioned so that subjects received 50 g available carbohydrate

Portion (Dry): 70 g Available CHO: 51.1 g
Active Comparator: Whole pea flour
Pasta made with 30% whole pea flour and 70% white wheat durum
Dietary supplement: Whole pea pasta

Dose was portioned so that subjects received 50 g available carbohydrate Pea pasta is 30% whole pea pasta, 70 white wheat durum

Portion (Dry pasta) : 90 g Available CHO: 53.1 g
Placebo Comparator: White bread
Dietary supplement: White bread

Dose was portioned so that subjects received 50 g available carbohydrate

Portion: 100 g Available CHO: 50 g
Placebo Comparator: Boiled yellow peas
Dietary supplement: Boiled yellow peas

Dose was portioned so that subjects received 50 g available carbohydrate

Portion: 100 g (dry) --> 250 g cooked Available CHO: 52.8 g

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
Post-prandial glycemic response

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
Comparison of hedonic sensory characteristics between corresponding food products
Appearance, taste, texture, smell and overall acceptability

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pulse Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter JH Jones, PhD, University of Manitoba

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

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.
March 1, 2008

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.
May 1, 2008

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).
April 7, 2009

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.
April 7, 2009

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.
April 8, 2009

Study Record Updates

Last Update Posted (Estimate)

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.
April 8, 2009

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.
April 7, 2009

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, 2009

More Information

Terms related to this study

Keywords

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.
  • B2008:017

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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