DiabetesPhase 2NCT00877968
Glycemic Responses and Sensory Characteristics of Whole Yellow Pea Flour Added to Novel Functional Foods
A Phase 2 study testing Whole wheat banana bread, Whole pea flour banana bread and Whole wheat biscotti in people with Diabetes, run by University of Manitoba at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Whole wheat banana bread, Whole pea flour banana bread and Whole wheat biscotti
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men
- non-lactating women
- BMI's between 18 and 31 kg/m2
Who cannot join
- heart disease
- diabetes
- thyroid disease
- celiac disease
- gluten intolerance
- taking corticosteroid medications
- smokers
- Chronic alcohol usage (> 2 drinks/d)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Whole wheat banana bread, Whole pea flour banana bread, Whole wheat biscotti, Whole pea flour biscotti, Whole wheat pasta
- Keywords
- Pea flour, Glycemic response, Diabetes, Sensory, Functional food, Diabetes control and prevention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole wheat banana breadDietary supplement
Dose was portioned so that subjects received 50 g available carbohydrate
Portion: 62.8 g Available CHO: 51.7 g
Whole pea flour banana breadDietary supplement
Dose was portioned so that subjects received 50 g available carbohydrate
Portion: 67.8 g Available CHO: 52.0 g
Whole wheat biscottiDietary supplement
Dose was portioned so that subjects received 50 g available carbohydrate
Portion: 79.8 g Available CHO: 53.1 g
Whole pea flour biscottiDietary supplement
Dose was portioned so that subjects received 50 g available carbohydrate
Portion: 86 g Available CHO: 51.7 g
Whole wheat pastaDietary supplement
Dose was portioned so that subjects received 50 g available carbohydrate
Portion (Dry): 70 g Available CHO: 51.1 g
Whole pea pastaDietary supplement
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
White breadDietary supplement
Dose was portioned so that subjects received 50 g available carbohydrate
Portion: 100 g Available CHO: 50 g
Boiled yellow peasDietary supplement
Dose was portioned so that subjects received 50 g available carbohydrate
Portion: 100 g (dry) --> 250 g cooked Available CHO: 52.8 g
| Study group | Role | What they receive |
|---|---|---|
| Whole wheat banana bread | Placebo comparator | Banana bread made with whole wheat flour Receives: Dietary Supplement: Whole wheat banana bread |
| Whole pea flour banana bread | Active comparator | Banana bread made with whole pea flour Receives: Dietary Supplement: Whole pea flour banana bread |
| Whole wheat biscotti | Placebo comparator | Biscotti made with whole wheat flour Receives: Dietary Supplement: Whole wheat biscotti |
| Whole pea biscotti | Active comparator | Biscotti made with whole pea flour Receives: Dietary Supplement: Whole pea flour biscotti |
| Whole wheat pasta | Placebo comparator | Pasta made with whole wheat durum Receives: Dietary Supplement: Whole wheat pasta |
| Whole pea flour | Active comparator | Pasta made with 30% whole pea flour and 70% white wheat durum Receives: Dietary Supplement: Whole pea pasta |
| White bread | Placebo comparator | Not described Receives: Dietary Supplement: White bread |
| Boiled yellow peas | Placebo comparator | Not described Receives: Dietary Supplement: Boiled yellow peas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glycemic response
Secondary outcomes (2)
Comparison of hedonic sensory characteristics between corresponding food products
Appearance, taste, texture, smell and overall acceptability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Pulse Canada
- Investigators
- Peter JH Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877968
- Sponsor's protocol ID
- B2008:017
- Status last verified
- Apr 2009
- First submitted
- 7 Apr 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Marinangeli CP, Kassis AN, Jones PJ. Glycemic responses and sensory characteristics of whole yellow pea flour added to novel functional foods. J Food Sci. 2009 Nov-Dec;74(9):S385-9. doi: 10.1111/j.1750-3841.2009.01347.x.
PubMed 20492127
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Responses and Sensory Characteristics of Whole Yellow Pea Flour Added to Novel Functional Foods
- ClinicalTrials.gov ID
- NCT00877968
- Acronym / sponsor ID
- B2008:017
- Conditions
- Diabetes
- Keywords
- Pea flour, Glycemic response, Diabetes, Sensory, Functional food, Diabetes control and prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Pulse Canada
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Whole wheat banana bread | Placebo comparator | Dietary Supplement: Whole wheat banana breadBanana bread made with whole wheat flour |
| Whole pea flour banana bread | Active comparator | Dietary Supplement: Whole pea flour banana breadBanana bread made with whole pea flour |
| Whole wheat biscotti | Placebo comparator | Dietary Supplement: Whole wheat biscottiBiscotti made with whole wheat flour |
| Whole pea biscotti | Active comparator | Dietary Supplement: Whole pea flour biscottiBiscotti made with whole pea flour |
| Whole wheat pasta | Placebo comparator | Dietary Supplement: Whole wheat pastaPasta made with whole wheat durum |
| Whole pea flour | Active comparator | Dietary Supplement: Whole pea pastaPasta made with 30% whole pea flour and 70% white wheat durum |
| White bread | Placebo comparator | Dietary Supplement: White bread |
| Boiled yellow peas | Placebo comparator | Dietary Supplement: Boiled yellow peas |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy men
- non-lactating women
- BMI's between 18 and 31 kg/m2
Key exclusion criteria (8 listed)
- heart disease
- diabetes
- thyroid disease
- celiac disease
- gluten intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole wheat banana breadDose was portioned so that subjects received 50 g available carbohydrate Portion: 62.8 g Available CHO: 51.7 g | Dietary supplement | Whole wheat banana bread |
| Whole pea flour banana breadDose was portioned so that subjects received 50 g available carbohydrate Portion: 67.8 g Available CHO: 52.0 g | Dietary supplement | Whole pea flour banana bread |
| Whole wheat biscottiDose was portioned so that subjects received 50 g available carbohydrate Portion: 79.8 g Available CHO: 53.1 g | Dietary supplement | Whole wheat biscotti |
| Whole pea flour biscottiDose was portioned so that subjects received 50 g available carbohydrate Portion: 86 g Available CHO: 51.7 g | Dietary supplement | Whole pea biscotti |
| Whole wheat pastaDose was portioned so that subjects received 50 g available carbohydrate Portion (Dry): 70 g Available CHO: 51.1 g | Dietary supplement | Whole wheat pasta |
| Whole pea pastaDose 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 | Dietary supplement | Whole pea flour |
| White breadDose was portioned so that subjects received 50 g available carbohydrate Portion: 100 g Available CHO: 50 g | Dietary supplement | White bread |
| Boiled yellow peasDose was portioned so that subjects received 50 g available carbohydrate Portion: 100 g (dry) --> 250 g cooked Available CHO: 52.8 g | Dietary supplement | Boiled yellow peas |
Primary outcome
Post-prandial glycemic response
2 secondary outcomes
Comparison of hedonic sensory characteristics between corresponding food products
Appearance, taste, texture, smell and overall acceptability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
- Derived from this study: PubMed 20492127Marinangeli CP, Kassis AN, Jones PJ. Glycemic responses and sensory characteristics of whole yellow pea flour added to novel functional foods. J Food Sci. 2009 Nov-Dec;74(9):S385-9. doi: 10.1111/j.1750-3841.2009.01347.x.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter JH Jones, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole wheat banana bread, Whole pea flour banana bread and Whole wheat biscotti in people with Diabetes, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial glycemic response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2009; AzTrials last refreshed its copy on 8 Nov 2026.