DiabetesNCT02402517
PERFECT Project - Part 2 - Study 1
A study testing Small particle size pea flour, Large particle size pea flour and Lentil flour in people with Diabetes and Obesity, run by University of Manitoba at 1 site in Canada.
Trial summary
The objectives are to test the acute effects of different extruded pulse snacks on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite on 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
- What is being tested?
- Small particle size pea flour, Large particle size pea flour and Lentil flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to 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)
- BMI of 18.5-29.9 kg/m2
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
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 1
The objectives are to test the acute effects of different extruded pulse snacks on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite on an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of food products 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 extruded pulse snacks 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.
- Being tested
- Control, Small particle size pea flour, Large particle size pea flour, Lentil flour, Navy bean flour
- Keywords
- Diabetes Prevention, Obesity Prevention
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Non pulse extruded snack
Small particle size pea flourOther
Pulse extruded snack
Large particle size pea flourOther
Pulse extruded snack
Lentil flourOther
Pulse extruded snack
Navy bean flourOther
Pulse extruded snack
Pinto bean flourOther
Pulse extruded snack
| Study group | Role | What they receive |
|---|---|---|
| Extruded snack control | Placebo comparator | 100% corn flour Receives: Other: Control |
| Extruded snack with small particle size pea flour | Experimental | 60% corn flour and 40% small particle size pea flour Receives: Other: Small particle size pea flour |
| Extruded snack with large particle size pea flour | Experimental | 60% corn flour and 40% large particle size pea flour Receives: Other: Large particle size pea flour |
| Extruded snack with lentil flour | Experimental | 60% corn flour and 40% lentil flour Receives: Other: Lentil flour |
| Extruded snack navy bean flour | Experimental | 60% corn flour and 40% navy bean flour Receives: Other: Navy bean flour |
| Extruded snack with pinto bean flour | Experimental | 60% corn flour and 40% pinto bean flour Receives: Other: Pinto bean flour |
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 at 14 time points, used to calculate area under curve (AUC). Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits. (Composite measure)
Measured: 0 - 240 min
Food Intake
Ad-libitum meal. Food consumed measured by weight.
Measured: at 120 min
Subjective Appetite
Measured by VAS questionnaire at 14 time points, used to calculate area under curve (AUC).( Composite measure)
Measured: 0-240 min
Exercise intensity
Sixty minute exercise protocol at minutes 60 to 120. Oxygen consumption measured during exercise at 3 time points.
Measured: 60 minutes
Secondary outcomes (7)
Lactate concentration
60 minute exercise protocol at minutes 60 to 120. Measured before, during, and exercise exercise at 3 time points
Measured: 60 minutes
Palatability of treatments
Measured by VAS questionnaire
Measured: at 5 minutes
Palatability of meal
Measured by VAS questionnaire
Measured: at 260 minutes
Physical comfort
Measured by VAS questionnaire at 13 time points, used to calculate area under curve (AUC) (Composite measure)
Measured: 0-240 min
Energy/fatigue
Measured by VAS questionnaire at 13 time points, used to calculate area under curve (AUC) (Composite measure)
Measured: 0-240 min
Heart rate
Heart rate monitored over a 60 minute exercise protocol. To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)
Measured: 60-120 min
Substrate Oxidation
Measured during 60 minute exercise protocol at minutes 60-120. Respiratory quotient measured during exercise at 3 time points.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startAug 2015
- 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 DiabetesStudies 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 (estimated)
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
- NCT02402517
- Sponsor's protocol ID
- B2014:114-2
- Status last verified
- May 2017
- First submitted
- 17 Dec 2014
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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 1
- ClinicalTrials.gov ID
- NCT02402517
- Acronym / sponsor ID
- B2014:114-2
- Keywords
- Diabetes Prevention, Obesity Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers, Alberta Pulse Growers
- Study start
- Aug 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Mar 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 extruded pulse snacks on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite on an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of food products 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 extruded pulse snacks 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 |
|---|---|---|
| Extruded snack control | Placebo comparator | Other: Control100% corn flour |
| Extruded snack with small particle size pea flour | Experimental | Other: Small particle size pea flour60% corn flour and 40% small particle size pea flour |
| Extruded snack with large particle size pea flour | Experimental | Other: Large particle size pea flour60% corn flour and 40% large particle size pea flour |
| Extruded snack with lentil flour | Experimental | Other: Lentil flour60% corn flour and 40% lentil flour |
| Extruded snack navy bean flour | Experimental | Other: Navy bean flour60% corn flour and 40% navy bean flour |
| Extruded snack with pinto bean flour | Experimental | Other: Pinto bean flour60% corn flour and 40% pinto bean flour |
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)
- BMI of 18.5-29.9 kg/m2
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 extruded snack | Other | Extruded snack control |
| Small particle size pea flourPulse extruded snack | Other | Extruded snack with small particle size pea flour |
| Large particle size pea flourPulse extruded snack | Other | Extruded snack with large particle size pea flour |
| Lentil flourPulse extruded snack | Other | Extruded snack with lentil flour |
| Navy bean flourPulse extruded snack | Other | Extruded snack navy bean flour |
| Pinto bean flourPulse extruded snack | Other | Extruded snack with pinto bean flour |
Primary outcome
Plasma Glucose and Insulin Concentrations
Time frame: 0 - 240 min
Measured in blood using intravenous catheter at 14 time points, used to calculate area under curve (AUC). Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits. (Composite measure)
Food Intake
Time frame: at 120 min
Ad-libitum meal. Food consumed measured by weight.
Subjective Appetite
Time frame: 0-240 min
Measured by VAS questionnaire at 14 time points, used to calculate area under curve (AUC).( Composite measure)
Exercise intensity
Time frame: 60 minutes
Sixty minute exercise protocol at minutes 60 to 120. Oxygen consumption measured during exercise at 3 time points.
7 secondary outcomes
Lactate concentration
Time frame: 60 minutes
Palatability of treatments
Time frame: at 5 minutes
Palatability of meal
Time frame: at 260 minutes
Physical comfort
Time frame: 0-240 min
Energy/fatigue
Time frame: 0-240 min
Heart rate
Time frame: 60-120 min
Substrate Oxidation
Time frame: 60 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 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 Small particle size pea flour, Large particle size pea flour and Lentil flour in people with Diabetes and Obesity, 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 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. 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 - 240 min). 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.