Metabolic SyndromeNCT01410851
Pulses, Satiation, Food Intake and Blood Glucose
A study testing dietary treatment in people with Metabolic Syndrome, run by University of Toronto at 1 site in Canada.
Trial summary
Pulses have the potential to be positioned as a food for body weight and metabolic control based on their composition, effects on rate of digestion and absorption of fat and carbohydrates, and effects on satiety. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- dietary treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Oct 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young males with BMI of 20-24.9 kg/m2
Who cannot join
- Females
- Smokers
- Breakfast skippers
- Individuals with diabetes or other metabolic diseases
- Those scoring ≥ 11 on an Eating Habit Questionnaire
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Nutritional Sciences, University of Toronto
Toronto, Ontario, M5S 3E2
About this study
Official title: The Acute Effects of Pulse Consumption on Glycaemic Responses and Measures of Satiety and Satiation
Pulses have the potential to be positioned as a food for body weight and metabolic control based on their composition, effects on rate of digestion and absorption of fat and carbohydrates, and effects on satiety. However, the role of individual pulses incorporated into a mixed meal on regulation of food intake, satiety and glycaemic control remains unclear. Therefore, the objective of our study was to determine the effects of ad libitum consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.
- Conditions
- Metabolic Syndrome
- Being tested
- dietary treatment
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary treatmentOther
A within-subject, balanced repeated-measures design was followed where subjects received 4 treatments or control over 5 weeks approximately 1 week apart. The pulse treatments contained: (1) chickpeas (Primo, Toronto, ON), (2) lentils (Primo, Toronto, ON), (3) navy beans (Ferma, Toronto, ON) or (4) yellow peas (Nupak, Toronto, ON).
| Study group | Role | What they receive |
|---|---|---|
| Pasta, tomato sauce & added chickpeas | Experimental | The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. Receives: Other: dietary treatment |
| Pasta, tomato sauce and added lentils | Experimental | The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. Receives: Other: dietary treatment |
| Pasta, tomato sauce and added navy beans | Experimental | The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. Receives: Other: dietary treatment |
| Pasta, tomato sauce with yellow peas | Experimental | The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. Receives: Other: dietary treatment |
| Pasta and tomato sauce | Experimental | The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. Receives: Other: dietary treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term energy intake
Energy intake was measured at the treatment meal (0-20 min) and at a pizza meal (second meal) provided four hours later (260-280 min).
Measured: over 280 min
Secondary outcomes (1)
Blood glucose and satiety
Following treatment meal consumption, blood glucose and appetite were measured at 20, 40, 60, 110, 140, 200 and 260 min and are reported as pre-second meal values. Following the pizza meal, blood glucose and appetite were measured at 280, 300, 320 and 340 min and are reported as post-second meal values.
Measured: 20, 40, 60, 110, 140, 200, 260, 280, 300, 320 and 340 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Investigators
- G. Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410851
- Sponsor's protocol ID
- PURENet:-Pulses and Satiation
- Status last verified
- Jul 2011
- First submitted
- 27 Jul 2011
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Pulse Consumption on Glycaemic Responses and Measures of Satiety and Satiation
- ClinicalTrials.gov ID
- NCT01410851
- Acronym / sponsor ID
- PURENet:-Pulses and Satiation
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Aug 2011 (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.
Pulses have the potential to be positioned as a food for body weight and metabolic control based on their composition, effects on rate of digestion and absorption of fat and carbohydrates, and effects on satiety. However, the role of individual pulses incorporated into a mixed meal on regulation of food intake, satiety and glycaemic control remains unclear. Therefore, the objective of our study was to determine the effects of ad libitum consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pasta, tomato sauce & added chickpeas | Experimental | Other: dietary treatmentThe pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. |
| Pasta, tomato sauce and added lentils | Experimental | Other: dietary treatmentThe pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. |
| Pasta, tomato sauce and added navy beans | Experimental | Other: dietary treatmentThe pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. |
| Pasta, tomato sauce with yellow peas | Experimental | Other: dietary treatmentThe pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. |
| Pasta and tomato sauce | Experimental | Other: dietary treatmentThe pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young males with BMI of 20-24.9 kg/m2
Key exclusion criteria (5 listed)
- Females
- Smokers
- Breakfast skippers
- Individuals with diabetes or other metabolic diseases
- Those scoring ≥ 11 on an Eating Habit Questionnaire
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 |
|---|---|---|
| dietary treatmentA within-subject, balanced repeated-measures design was followed where subjects received 4 treatments or control over 5 weeks approximately 1 week apart. The pulse treatments contained: (1) chickpeas (Primo, Toronto, ON), (2) lentils (Primo, Toronto, ON), (3) navy beans (Ferma, Toronto, ON) or (4) yellow peas (Nupak, Toronto, ON). | Other | Pasta and tomato sauce, Pasta, tomato sauce & added chickpeas, Pasta, tomato sauce and added lentils, Pasta, tomato sauce and added navy beans, Pasta, tomato sauce with yellow peas |
Primary outcome
Short-term energy intake
Time frame: over 280 min
Energy intake was measured at the treatment meal (0-20 min) and at a pizza meal (second meal) provided four hours later (260-280 min).
1 secondary outcome
Blood glucose and satiety
Time frame: 20, 40, 60, 110, 140, 200, 260, 280, 300, 320 and 340 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 5 Aug 2011.
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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, PhD 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 dietary treatment in people with Metabolic Syndrome, 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 5 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 5 Aug 2011. 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?
Short-term energy intake (time frame: over 280 min). 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 5 Aug 2011.