ObesityNCT01242059
Yellow Pea Fractions and Short-term Food Intake, Subjective Appetite and Glycemic Response
A study testing yellow pea protein and yellow pea fiber in people with Obesity and Type II Diabetes Mellitus, run by University of Toronto at 1 site in Canada.
Trial summary
It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response. Read more about this study
- Who is it for?
- Ages 20 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type II Diabetes Mellitus, Metabolic Syndrome
- What is being tested?
- yellow pea protein and yellow pea fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Dec 2010
- 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 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male 20-30 years old healthy weight
Who cannot join
- smoking restrictive eating metabolic diseases breakfast skippers dieters
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto - Department of Nutritional Sciences
Toronto, Ontario, M5S 3E2
About this study
Official title: Effect of Yellow Pea Fractions on Short-term Food Intake at 120 Minutes, Subjective Appetite and Glycemic Response in Young Adult Males
It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.
Read the detailed description
A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 2 hours after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.
- Conditions
- Obesity, Type II Diabetes Mellitus, Metabolic Syndrome
- Being tested
- yellow pea protein, yellow pea fiber, Control
- Keywords
- Obesity, Food intake regulation, blood glucose regulation, protein, fiber, pulses, yellow peas
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yellow pea proteinDietary supplement
Served in a tomato soup
yellow pea fiberOther
Served in a tomato soup
ControlDietary supplement
Served in a tomato soup
| Study group | Role | What they receive |
|---|---|---|
| Control Tomato Soup | Experimental | Not described Receives: Dietary Supplement: Control |
| 10 g of yellow pea fiber | Experimental | Not described Receives: Other: yellow pea fiber |
| 20 g of yellow pea fiber | Experimental | Not described Receives: Other: yellow pea fiber |
| 10 g of yellow pea protein | Experimental | Not described Receives: Dietary Supplement: yellow pea protein |
| 20 g of yellow pea protein | Experimental | Not described Receives: Dietary Supplement: yellow pea protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Intake
Energy intake at an ad libitum pizza meal
Measured: at 120 minutes after treatment
Secondary outcomes (2)
Glycemic Response
Measured: 200 minutes
Subjective Appetite
Measured: 200 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionDec 2010
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Pulse Canada
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G Harvey Anderson, Ph.D, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242059
- Sponsor's protocol ID
- PureNet_23281
- Status last verified
- Jun 2012
- First submitted
- 12 Nov 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yellow Pea Fractions on Short-term Food Intake at 120 Minutes, Subjective Appetite and Glycemic Response in Young Adult Males
- ClinicalTrials.gov ID
- NCT01242059
- Acronym / sponsor ID
- PureNet_23281
- Conditions
- Obesity, Type II Diabetes Mellitus, Metabolic Syndrome
- Keywords
- Obesity, Food intake regulation, blood glucose regulation, protein, fiber, pulses, yellow peas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Pulse Canada
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Nov 2010 (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.
It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.
Detailed description
A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 2 hours after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Tomato Soup | Experimental | Dietary Supplement: Control |
| 10 g of yellow pea fiber | Experimental | Other: yellow pea fiber |
| 20 g of yellow pea fiber | Experimental | Other: yellow pea fiber |
| 10 g of yellow pea protein | Experimental | Dietary Supplement: yellow pea protein |
| 20 g of yellow pea protein | Experimental | Dietary Supplement: yellow pea protein |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male 20-30 years old healthy weight
Key exclusion criteria (1 listed)
- smoking restrictive eating metabolic diseases breakfast skippers dieters
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 |
|---|---|---|
| yellow pea proteinServed in a tomato soup | Dietary supplement | 10 g of yellow pea protein, 20 g of yellow pea protein |
| yellow pea fiberServed in a tomato soup | Other | 10 g of yellow pea fiber, 20 g of yellow pea fiber |
| ControlServed in a tomato soup | Dietary supplement | Control Tomato Soup |
Primary outcome
Energy Intake
Time frame: at 120 minutes after treatment
Energy intake at an ad libitum pizza meal
2 secondary outcomes
Glycemic Response
Time frame: 200 minutes
Subjective Appetite
Time frame: 200 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 14 Jun 2012.
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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.
G Harvey Anderson, Ph.D principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yellow pea protein and yellow pea fiber in people with Obesity and Type II Diabetes Mellitus, run by University of Toronto 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 1 inclusion and 1 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 14 Jun 2012. 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?
Energy Intake (time frame: at 120 minutes after treatment). 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 14 Jun 2012.