Diabetes PreventionNCT02365363
PERFECT Project - Part 2 - Study 3
A study testing Pea flour, Pea fibre and Pea flour and pea fibre 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 bagels 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 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention, Obesity Prevention
- What is being tested?
- Pea flour, Pea fibre and Pea flour and pea fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to 19 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
None listed.
Who cannot join
- Restrained eaters
- Regularly skip breakfast
- Smokers
- Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
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 3
The objectives are to test the acute effects of different bagels 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. We hypothesize that consumption of bagels 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. We also hypothesize that consumption of bagels 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 flour, Pea fibre, Pea flour and pea fibre, Pea flour and pea protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Non pulse ingredient bagel
Pea flourOther
Pulse ingredient bagel
Pea fibreOther
Pulse ingredient bagel
Pea flour and pea fibreOther
Pulse ingredient bagel
Pea flour and pea proteinOther
Pulse ingredient bagel
Pea flour + pea fibre + pea proteinOther
Pulse ingredient bagel
| Study group | Role | What they receive |
|---|---|---|
| Bagel control | Experimental | 100% wheat flour Receives: Other: Control |
| Bagel with pea flour | Experimental | Pea flour (30%) Receives: Other: Pea flour |
| Bagel with pea fibre | Experimental | Pea fibre (11g) Receives: Other: Pea fibre |
| Bagel w/ pea flour + pea fibre | Experimental | Pea flour (30%) + pea fibre (11g) Receives: Other: Pea flour and pea fibre |
| Bagel w/ pea flour + pea protein | Experimental | Pea flour (30%) + pea protein (24g) Receives: Other: Pea flour and pea protein |
| Bagel w/ pea flour + pea fibre + pea protein | Experimental | Pea flour (30%) + pea fibre (11g) + pea protein (24g) Receives: Other: Pea flour + pea fibre + pea protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose and Insulin Concentrations
Measured in blood using intravenous catheter. Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits
Measured: 0-240
Food Intake
Ad-libitum meal
Measured: 120 min
Subjective Appetite
Motivation-to-eat VAS questionnaire
Measured: 0-240 min
Exercise intensity
Oxygen consumption measured during exercise at 3 time points
Measured: 60-120 min
Secondary outcomes (6)
Palatability
Measured by VAS questionnaire
Measured: 5 and 260 min
Physical comfort
Measured by VAS questionnaire
Measured: 0-240 min
Energy/fatigue
Measured by VAS questionnaire
Measured: 0 - 240 min
Heart rate
To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)
Measured: 60-120 min
Lactate concentration
Measured before, during, and exercise exercise at 3 time points
Measured: 60-120 min
Substrate Oxidation
Respiratory quotient measured during exercise at 3 time points
Measured: 60-120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startOct 2016
- Primary completion19 Dec 2017
- Study completion19 Dec 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
- Other
- 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
- NCT02365363
- Sponsor's protocol ID
- B2014:114-6
- Status last verified
- Apr 2021
- First submitted
- 17 Dec 2014
- Last updated
- 23 Jan 2023
- Results posted
- No
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 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 3
- ClinicalTrials.gov ID
- NCT02365363
- Acronym / sponsor ID
- B2014:114-6
- 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
- Oct 2016
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 18 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 bagels 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. We hypothesize that consumption of bagels 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. We also hypothesize that consumption of bagels 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Bagel control | Experimental | Other: Control100% wheat flour |
| Bagel with pea flour | Experimental | Other: Pea flourPea flour (30%) |
| Bagel with pea fibre | Experimental | Other: Pea fibrePea fibre (11g) |
| Bagel w/ pea flour + pea fibre | Experimental | Other: Pea flour and pea fibrePea flour (30%) + pea fibre (11g) |
| Bagel w/ pea flour + pea protein | Experimental | Other: Pea flour and pea proteinPea flour (30%) + pea protein (24g) |
| Bagel w/ pea flour + pea fibre + pea protein | Experimental | Other: Pea flour + pea fibre + pea proteinPea flour (30%) + pea fibre (11g) + pea protein (24g) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Restrained eaters
- Regularly skip breakfast
- Smokers
- Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
- 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 ingredient bagel | Other | Bagel control |
| Pea flourPulse ingredient bagel | Other | Bagel with pea flour |
| Pea fibrePulse ingredient bagel | Other | Bagel with pea fibre |
| Pea flour and pea fibrePulse ingredient bagel | Other | Bagel w/ pea flour + pea fibre |
| Pea flour and pea proteinPulse ingredient bagel | Other | Bagel w/ pea flour + pea protein |
| Pea flour + pea fibre + pea proteinPulse ingredient bagel | Other | Bagel w/ pea flour + pea fibre + pea protein |
Primary outcome
Plasma Glucose and Insulin Concentrations
Time frame: 0-240
Measured in blood using intravenous catheter. 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: 120 min
Ad-libitum meal
Subjective Appetite
Time frame: 0-240 min
Motivation-to-eat VAS questionnaire
Exercise intensity
Time frame: 60-120 min
Oxygen consumption measured during exercise at 3 time points
6 secondary outcomes
Palatability
Time frame: 5 and 260 min
Physical comfort
Time frame: 0-240 min
Energy/fatigue
Time frame: 0 - 240 min
Heart rate
Time frame: 60-120 min
Lactate concentration
Time frame: 60-120 min
Substrate Oxidation
Time frame: 60-120 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.
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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 flour, Pea fibre and Pea flour and pea fibre 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 0 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.
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. 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: 0-240). The study lists 4 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 23 Jan 2023.