ObesityNCT02015429
Effect of Yellow Pea Protein and Fibre Added to a High-carb Meal on Glycemic Response and Food Intake
A study of Obesity and Diabetes, run by University of Toronto at 2 sites in Canada.
Trial summary
The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2007to Dec 2008
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking
- No metabolic disease
- BMI 20 - 25 kg/m^2
- male
- age 20-30
Who cannot join
- Intolerance to treatments
- on appetite-modifying medications
- restrictive eating
- smoking
- over or underweight
- breakfast-skipping
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Toronto - Department of Nutritional Sciences
Toronto, Ontario, M5S 3E2
University of Toronto
Toronto, Ontario, M5S 3E2
About this study
The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later.
- Being tested
- Pasta meal with added fractions or control with no fractions
- Keywords
- Food intake, satiety, glycemia, appetite, blood glucose, yellow peas, fibre, protein, mixed meal
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasta meal with added fractions or control with no fractionsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Pasta meal with added fractions or control with no fractions Pasta meal with no pea fractions Receives: Dietary Supplement: Pasta meal with added fractions or control with no fractions |
| 10 g protein | Experimental | Pasta meal with added fractions or control with no fractions 10 g net yellow pea protein added to pasta meal Receives: Dietary Supplement: Pasta meal with added fractions or control with no fractions |
| 7 g yellow pea fibre | Experimental | Pasta meal with added fractions or control with no fractions 7 g net yellow pea fibre added to pasta meal Receives: Dietary Supplement: Pasta meal with added fractions or control with no fractions |
| Yellow pea fibre & protein | Experimental | Pasta meal with added fractions or control with no fractions 10 g net yellow pea protein plus 7 g net yellow pea fibre added to pasta meal Receives: Dietary Supplement: Pasta meal with added fractions or control with no fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum food intake at second pizza meal
Food intake measured via electronic scale in g, then converted to kcal using the caloric density.
Measured: 135 mins after completion of treatment, 20 mins to eat pizza meal.
Blood glucose
Blood glucose measured via hand-held glucometer and finger prick.
Measured: between 0 and 215 mins, every 15-30 mins
Secondary outcomes (1)
Subjective appetite
Measured via Visual Analog Scales (VAS)
Measured: 0 to 215 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- Harvey G Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015429
- Sponsor's protocol ID
- Pea_Fractionation_mixed_meal
- Status last verified
- Dec 2013
- First submitted
- 9 Dec 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yellow Pea Protein and Fibre Added to a High-carb Meal on Glycemic Response and Food Intake
- ClinicalTrials.gov ID
- NCT02015429
- Acronym / sponsor ID
- Pea_Fractionation_mixed_meal
- Keywords
- Food intake, satiety, glycemia, appetite, blood glucose, yellow peas, fibre, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Dec 2013 (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 investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Dietary Supplement: Pasta meal with added fractions or control with no fractionsPasta meal with added fractions or control with no fractions Pasta meal with no pea fractions |
| 10 g protein | Experimental | Dietary Supplement: Pasta meal with added fractions or control with no fractionsPasta meal with added fractions or control with no fractions 10 g net yellow pea protein added to pasta meal |
| 7 g yellow pea fibre | Experimental | Dietary Supplement: Pasta meal with added fractions or control with no fractionsPasta meal with added fractions or control with no fractions 7 g net yellow pea fibre added to pasta meal |
| Yellow pea fibre & protein | Experimental | Dietary Supplement: Pasta meal with added fractions or control with no fractionsPasta meal with added fractions or control with no fractions 10 g net yellow pea protein plus 7 g net yellow pea fibre added to pasta meal |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoking
- No metabolic disease
- BMI 20 - 25 kg/m^2
- male
- age 20-30
Key exclusion criteria (6 listed)
- Intolerance to treatments
- on appetite-modifying medications
- restrictive eating
- smoking
- over or underweight
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 |
|---|---|---|
| Pasta meal with added fractions or control with no fractions | Dietary supplement | 10 g protein, 7 g yellow pea fibre, Control, Yellow pea fibre & protein |
Primary outcome
Ad libitum food intake at second pizza meal
Time frame: 135 mins after completion of treatment, 20 mins to eat pizza meal.
Food intake measured via electronic scale in g, then converted to kcal using the caloric density.
Blood glucose
Time frame: between 0 and 215 mins, every 15-30 mins
Blood glucose measured via hand-held glucometer and finger prick.
1 secondary outcome
Subjective appetite
Time frame: 0 to 215 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 19 Dec 2013.
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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.
Harvey G Anderson, PhD principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity and Diabetes, run by University of Toronto at 2 sites 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 5 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 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Ad libitum food intake at second pizza meal (time frame: 135 mins after completion of treatment, 20 mins to eat pizza meal.). The study lists 2 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 19 Dec 2013.