Diabetes PreventionNCT02370927
PERFECT Project - Part 2 - 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 at 1 site in Canada.
Trial summary
The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. Read more about this study
- Who is it for?
- Ages 18 to 50 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 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 50 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)
- Body Mass Index of 18.5-29.9 kg/m2
Who cannot join
- Restrained eaters
- Regularly skip breakfast
- Smokers
- Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year
- Those who are active (organized activities or athletic training at a high intensity; ≥ 150 minutes per week of moderate to vigorous physical activity)
- Those unable to walk for an hour continuously
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
Official title: Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 2 - Acute Effects of Pulse Ingredients in Food Products on Aerobic Endurance and Substrate Oxidation During Exercise, as Well as, the Blood Glucose, Insulin, Lactate and Food Intake Response Following an Endurance Exercise Session in Adults - Study 2
The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of cereals containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. The investigators also hypothesize that consumption of cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.
- 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 |
|---|---|---|
| Control | Placebo comparator | 100% Wheat Flour Receives: Other: Control |
| Cereal w/ pea protein | Experimental | Pea protein Receives: Other: Pea protein |
| Cereal w/ pea starch | Experimental | Pea starch Receives: Other: Pea Starch |
| Cereal w/ pea starch + pea fibre | Experimental | Pea starch + pea fibre: 5g Receives: Other: Pea fibre + pea starch |
| Cereal w/ pea protein + pea starch | Experimental | Pea protein + pea starch: 10g Receives: Other: Pea protein + pea starch |
| Cereal w/ pea protein + pea fibre + pea starch: | 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 Concentrations
Measured in blood using intravenous catheter. Glucose will be determined by automated methods using Abbot Spectrum Clinical Chemistry-X Analyzer,
Measured: 0-240 minutes
Food Intake
Ad-libitum meal
Measured: at 240 minutes
Subjective Appetite
Motivation-to-eat Visual Analog Scale questionnaire
Measured: 0-240 minutes
Exercise intensity
Oxygen consumption measured during exercise at 3 time points
Measured: 60-120 minutes
Insulin concentrations
Measured in blood using intravenous catheter. and Insulin will be measured by commercially available radioimmunoassay (RIA) kits
Measured: 0-240 minutes
Secondary outcomes (6)
Palatability measured by Visual Analog Scale questionnaire
Food tasting
Measured: 5 and 260 minutes
Physical comfort measured by Visual Analog Scale questionnaire
Contributions from energy intake
Measured: 0-240 minutes
Energy/fatigue measured by Visual Analog Scale questionnaire
Estimate of energy expenditure
Measured: 0 - 240 minutes
Heart rate
To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)
Measured: 60-120 minutes
Substrate Oxidation
Respiratory quotient measured during exercise at 3 time points
Measured: 60-120 minutes
Lactate concentration
Measured before, during, and after exercise exercise at 3 time points
Measured: 60-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT02370927
- Sponsor's protocol ID
- B2014:114-4
- Status last verified
- Jul 2018
- First submitted
- 17 Dec 2014
- Last updated
- 26 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 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 2 - Acute Effects of Pulse Ingredients in Food Products on Aerobic Endurance and Substrate Oxidation During Exercise, as Well as, the Blood Glucose, Insulin, Lactate and Food Intake Response Following an Endurance Exercise Session in Adults - Study 2
- ClinicalTrials.gov ID
- NCT02370927
- Acronym / sponsor ID
- B2014:114-4
- Conditions
- Diabetes Prevention, Obesity Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers, Alberta Pulse Growers
- Study start
- May 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 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) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of cereals containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. The investigators also hypothesize that consumption of cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control100% Wheat Flour |
| Cereal w/ pea protein | Experimental | Other: Pea proteinPea protein |
| Cereal w/ pea starch | Experimental | Other: Pea StarchPea starch |
| Cereal w/ pea starch + pea fibre | Experimental | Other: Pea fibre + pea starchPea starch + pea fibre: 5g |
| Cereal w/ pea protein + pea starch | Experimental | Other: Pea protein + pea starchPea protein + pea starch: 10g |
| Cereal w/ pea protein + pea fibre + pea starch: | Experimental | Other: Pea fibre + pea starch + pea proteinPea protein + pea fibre + pea starch: 20g |
Who may qualify
- Ages
- 18 to 50 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)
- Body Mass Index of 18.5-29.9 kg/m2
Key exclusion criteria (6 listed)
- Restrained eaters
- Regularly skip breakfast
- Smokers
- Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year
- Those who are active (organized activities or athletic training at a high intensity; ≥ 150 minutes per week of moderate to vigorous physical activity)
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 | Control |
| Pea proteinPulse extruded cereal | Other | Cereal w/ pea protein |
| Pea StarchPulse extruded cereal | Other | Cereal w/ pea starch |
| Pea fibre + pea starchPulse extruded cereal | Other | Cereal w/ pea starch + pea fibre |
| Pea protein + pea starchPulse extruded cereal | Other | Cereal w/ pea protein + pea starch |
| Pea fibre + pea starch + pea proteinPulse extruded cereal | Other | Cereal w/ pea protein + pea fibre + pea starch: |
Primary outcome
Plasma Glucose Concentrations
Time frame: 0-240 minutes
Measured in blood using intravenous catheter. Glucose will be determined by automated methods using Abbot Spectrum Clinical Chemistry-X Analyzer,
Food Intake
Time frame: at 240 minutes
Ad-libitum meal
Subjective Appetite
Time frame: 0-240 minutes
Motivation-to-eat Visual Analog Scale questionnaire
Exercise intensity
Time frame: 60-120 minutes
Oxygen consumption measured during exercise at 3 time points
Insulin concentrations
Time frame: 0-240 minutes
Measured in blood using intravenous catheter. and Insulin will be measured by commercially available radioimmunoassay (RIA) kits
6 secondary outcomes
Palatability measured by Visual Analog Scale questionnaire
Time frame: 5 and 260 minutes
Physical comfort measured by Visual Analog Scale questionnaire
Time frame: 0-240 minutes
Energy/fatigue measured by Visual Analog Scale questionnaire
Time frame: 0 - 240 minutes
Heart rate
Time frame: 60-120 minutes
Substrate Oxidation
Time frame: 60-120 minutes
Lactate concentration
Time frame: 60-120 minutes
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 26 Jan 2023.
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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
1 site in 1 country: see every site and its status.
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 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 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 26 Jan 2023. 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.
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 Concentrations (time frame: 0-240 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2023.