Diabetes PreventionNCT02366572
PERFECT Project - Part 1 - Study 2
A study testing Pea protein, Pea starch and Pea fibre + pea starch in people with Diabetes Prevention and Obesity Prevention, run by University of Manitoba.
Trial summary
The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention, Obesity Prevention
- What is being tested?
- Pea protein, Pea starch and Pea fibre + pea starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2017
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normoglycemic (<5.6 mmol/L) and normotensive (systolic blood pressure <140 mm Hg and diastolic blood pressure below < 90 mm Hg)
- BMI of 18.5-29.9 kg/m2
Who cannot join
- Restrained eaters
- Regularly skip breakfast
- Smokers
- Competitive sports or athletic training at a high intensity
- Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
- Those unable to walk for an hour continuously
About this study
Official title: Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 2
The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.
We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse cereals.
- Conditions
- Diabetes Prevention, Obesity Prevention
- Being tested
- Control, Pea protein, Pea starch, Pea fibre + pea starch, Pea protein + pea starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Non pulse extruded cereal
Pea proteinOther
Pulse extruded cereal
Pea starchOther
Pulse extruded cereal
Pea fibre + pea starchOther
Pulse extruded cereal
Pea protein + pea starchOther
Pulse extruded cereal
Pea fibre + pea starch + pea proteinOther
Pulse extruded cereal
| Study group | Role | What they receive |
|---|---|---|
| Cereal control | Placebo comparator | 100% Wheat Flour Receives: Other: Control |
| Cereal with pea protein | Experimental | Pea protein Receives: Other: Pea protein |
| Cereal with pea starch | Experimental | Pea starch Receives: Other: Pea starch |
| Cereal w/ pea starch + pea fibre: 5g | Experimental | Pea starch + pea fibre: 5g Receives: Other: Pea fibre + pea starch |
| Cereal w/ pea protein + pea starch: 10g | Experimental | Pea protein + pea starch: 10g Receives: Other: Pea protein + pea starch |
| Cereal w/ pea protein + pea fibre + pea starch: 20g | Experimental | Pea protein + pea fibre + pea starch: 20g Receives: Other: Pea fibre + pea starch + pea protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose and Insulin Concentrations
Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits
Measured: 0 - 200 min
Food Intake
Measured by VAS questionnaire
Measured: at 120 min
Subjective Appetite
Motivation-to-eat VAS questionnaire
Measured: 0-200 min
Secondary outcomes (3)
Palatability of treaments and meal
Measured by VAS questionnaire
Measured: 5 and 140 minutes
Physical comfort
Measured by VAS questionnaire
Measured: 0 - 200 min
Energy/fatigue
Measured by VAS questionnaire
Measured: 0-200 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionDec 2017
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 Diabetes PreventionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Pulse Growers, Alberta Pulse Growers
- Responsible party
- Sponsor
- Investigators
- Peter JH Jones, PhD, Principal investigator, University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366572
- Sponsor's protocol ID
- B2014:114-3
- Status last verified
- Apr 2021
- First submitted
- 17 Dec 2014
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnston AJ, Mollard RC, Dandeneau D, MacKay DS, Ames N, Curran J, Bouchard DR, Jones PJ. Acute effects of extruded pea fractions on glycemic response, insulin, appetite, and food intake in healthy young adults, results of a double-blind, randomized crossover trial. Appl Physiol Nutr Metab. 2021 Sep;46(9):1126-1132. doi: 10.1139/apnm-2020-0571. Epub 2021 Mar 4.
PubMed 33661714
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 2
- ClinicalTrials.gov ID
- NCT02366572
- Acronym / sponsor ID
- B2014:114-3
- Conditions
- Diabetes Prevention, Obesity Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers, Alberta Pulse Growers
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Feb 2015 (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 objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.
We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse cereals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cereal control | Placebo comparator | Other: Control100% Wheat Flour |
| Cereal with pea protein | Experimental | Other: Pea proteinPea protein |
| Cereal with pea starch | Experimental | Other: Pea starchPea starch |
| Cereal w/ pea starch + pea fibre: 5g | Experimental | Other: Pea fibre + pea starchPea starch + pea fibre: 5g |
| Cereal w/ pea protein + pea starch: 10g | Experimental | Other: Pea protein + pea starchPea protein + pea starch: 10g |
| Cereal w/ pea protein + pea fibre + pea starch: 20g | Experimental | Other: Pea fibre + pea starch + pea proteinPea protein + pea fibre + pea starch: 20g |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normoglycemic (<5.6 mmol/L) and normotensive (systolic blood pressure <140 mm Hg and diastolic blood pressure below < 90 mm Hg)
- BMI of 18.5-29.9 kg/m2
Key exclusion criteria (6 listed)
- Restrained eaters
- Regularly skip breakfast
- Smokers
- Competitive sports or athletic training at a high intensity
- Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
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 |
|---|---|---|
| ControlNon pulse extruded cereal | Other | Cereal control |
| Pea proteinPulse extruded cereal | Other | Cereal with pea protein |
| Pea starchPulse extruded cereal | Other | Cereal with pea starch |
| Pea fibre + pea starchPulse extruded cereal | Other | Cereal w/ pea starch + pea fibre: 5g |
| Pea protein + pea starchPulse extruded cereal | Other | Cereal w/ pea protein + pea starch: 10g |
| Pea fibre + pea starch + pea proteinPulse extruded cereal | Other | Cereal w/ pea protein + pea fibre + pea starch: 20g |
Primary outcome
Plasma Glucose and Insulin Concentrations
Time frame: 0 - 200 min
Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits
Food Intake
Time frame: at 120 min
Measured by VAS questionnaire
Subjective Appetite
Time frame: 0-200 min
Motivation-to-eat VAS questionnaire
3 secondary outcomes
Palatability of treaments and meal
Time frame: 5 and 140 minutes
Physical comfort
Time frame: 0 - 200 min
Energy/fatigue
Time frame: 0-200 min
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 23 Jan 2023.
- Derived from this study: PubMed 33661714Johnston AJ, Mollard RC, Dandeneau D, MacKay DS, Ames N, Curran J, Bouchard DR, Jones PJ. Acute effects of extruded pea fractions on glycemic response, insulin, appetite, and food intake in healthy young adults, results of a double-blind, randomized crossover trial. Appl Physiol Nutr Metab. 2021 Sep;46(9):1126-1132. doi: 10.1139/apnm-2020-0571. Epub 2021 Mar 4.
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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, Richardson Centre for Functional Foods and Nutraceuticals
Questions about this trial
What is this clinical trial studying?
A study testing Pea protein, Pea starch and Pea fibre + pea starch in people with Diabetes Prevention and Obesity Prevention, run by University of Manitoba.
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 2 inclusion and 6 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 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Plasma Glucose and Insulin Concentrations (time frame: 0 - 200 min). The study lists 3 primary outcomes in all. 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 NCT02366572, 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 23 Jan 2023.