Diabetes PreventionPhase 1NCT01298154
Effects of Intact and Hydrolyzed Pea Protein on Food Intake, Glycemic Response and Subjective Appetite
A Phase 1 study testing Dietary intervention in people with Diabetes Prevention and Obesity Prevention, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this protocol is to study the effects of intact and hydrolyzed yellow pea protein, compared to intact and hydrolyzed whey protein, on satiety, food intake, and glucose metabolism in healthy young men. 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
- Diabetes Prevention, Obesity Prevention
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Feb 2011
- Phase
- Phase 1
- 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
- Non-smoking
- Aged 20-30 years
- Body mass index between 20 and 24.9 kg/m2
Who cannot join
- Diabetes
- Gastrointestinal conditions
- Medication
- Lactose-intolerance or allergies to milk (standard breakfast provided)
- Breakfast skippers and those on an energy restricted diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intact and Hydrolyzed Yellow Pea Protein on Food Intake, Glycemic Response, and Subjective Appetite in Healthy Young Men.
The purpose of this protocol is to study the effects of intact and hydrolyzed yellow pea protein, compared to intact and hydrolyzed whey protein, on satiety, food intake, and glucose metabolism in healthy young men. The specific objective is to investigate the effects of 20 g available protein for 4 different protein types (intact and hydrolyzed pea and whey proteins) and water (control) on satiety, food intake and blood glucose before and after a meal. The specified amount of protein was chosen based on our previous studies on intact pea protein suggesting that 20 g may reduce food intake and pre-meal blood glucose 30 minutes before a test meal. Whey protein has been chosen as a reference protein because it has been extensively studied and its effects on blood glucose and food intake are being elucidated within our laboratory.
Read the detailed description
According to the 2004 Canadian Community Health Survey, nearly two-thirds of Canadians are overweight or obese. Obesity is a major risk factor for the metabolic syndrome, which is linked to conditions such as type II diabetes. Dietary interventions that increase satiety (to promote weight loss) and maintain normal blood glucose levels are noninvasive and inexpensive compared to pharmacological strategies. Thus, it is important to identify types/sources of macronutrients that contribute to healthy body weight by increasing satiety and thereby reducing food intake. For instance, diets including pulses (legumes) have been linked with a lower risk of obesity/overweight.
Pulses are the edible seeds of legumes or pod-bearing plants including dry beans, yellow peas, lentils and chickpeas. They are inexpensive healthy foods high in protein and complex carbohydrates. Recently within our laboratory, we found that including 5 cups of pulses into the diet for 8 weeks was associated with decreased body weight, waist circumference and improved glycemic control. However, the mechanisms driving weight loss and improved glycemic control need further investigation. For instance, pulses may affect satiety, energy intake and blood glucose because of their high amounts of protein. Protein is known to be more satiating than carbohydrate and fat leading to a positive impact on long-term body weight maintenance. Protein from various animal and plant sources has also been shown to stimulate the release of satiety-related hormones like insulin, glucagon, glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK), peptide tyrosine tyrosine (PYY) and ghrelin.
The investigators recently investigated the independent dosage effects of pea protein (10 and 20 g) and pea fibre (10 and 20 g) on ad libitum food intake at 30 minutes and pre- (0-30 minutes) and post-meal (50-170 minutes) blood glucose response and subjective appetite in young men. Preliminary results indicate that increasing protein amounts (10 g versus 20 g) lead to decreased pre-meal blood glucose response and reduced food intake.
Food-grade proteins are also available intact and/or hydrolyzed (partially digested through a controlled enzymatic process). Hydrolyzed proteins are more easily digested and absorbed, eliciting a faster rise in plasma amino acids compared to intact proteins and different hormonal and metabolic responses between the two forms. As for pea protein, no data are available differentiating the effects of intact and hydrolyzed forms on these blood parameters and appetite in humans. Moreover, the presence of bioactive polypeptides may be affected by protein formulation (i.e. the polypeptides may be cleaved/inactivated in hydrolyzed pea protein).
Research is needed to determine whether the effect of pea protein differs on glycemic response and appetite both pre- and post-meal based on its form (intact versus hydrolyzed) and how it compares to other well-investigated proteins. This research is preliminary and may lead to future research in other population groups, including young women and overweight individuals. These results will encourage increased consumption of pulse fractions by providing a basis for the potential use of pea protein in the development of new functional foods aimed at preventing and managing obesity along with controlling blood glucose for diabetes management. Furthermore, results will show if pea protein is a comparable alternative to whey, which would be favorable for consumers shifting away from animal-derived proteins for health and/or environmental reasons.
- Conditions
- Diabetes Prevention, Obesity Prevention
- Being tested
- Dietary intervention
- Keywords
- Food intake, Blood glucose, Pulses, Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Dietary treatments with beverages
| Study group | Role | What they receive |
|---|---|---|
| Intact Pea Protein (20 g) | Experimental | Not described Receives: Other: Dietary intervention |
| Hydrolyzed Pea Protein (20 g) | Experimental | Not described Receives: Other: Dietary intervention |
| Intact Whey Protein | Experimental | Not described Receives: Other: Dietary intervention |
| Hydrolyzed Whey Protein | Experimental | Not described Receives: Other: Dietary intervention |
| Water | Experimental | Not described Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Intake
Measured: 30 minutes
Secondary outcomes (1)
Blood Glucose
Measured: 0, 15, 30, 50, 65, 80, 95, 110, 140 and 170 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionFeb 2011
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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Harvey Anderson, PHD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298154
- Sponsor's protocol ID
- PureNet_23878
- Other IDs
- peaprotein_486233
- Status last verified
- Feb 2011
- First submitted
- 14 Apr 2010
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intact and Hydrolyzed Yellow Pea Protein on Food Intake, Glycemic Response, and Subjective Appetite in Healthy Young Men.
- ClinicalTrials.gov ID
- NCT01298154
- Acronym / sponsor ID
- PureNet_23878
- Conditions
- Diabetes Prevention, Obesity Prevention
- Keywords
- Food intake, Blood glucose, Pulses, Protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 17 Feb 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.
The purpose of this protocol is to study the effects of intact and hydrolyzed yellow pea protein, compared to intact and hydrolyzed whey protein, on satiety, food intake, and glucose metabolism in healthy young men. The specific objective is to investigate the effects of 20 g available protein for 4 different protein types (intact and hydrolyzed pea and whey proteins) and water (control) on satiety, food intake and blood glucose before and after a meal. The specified amount of protein was chosen based on our previous studies on intact pea protein suggesting that 20 g may reduce food intake and pre-meal blood glucose 30 minutes before a test meal. Whey protein has been chosen as a reference protein because it has been extensively studied and its effects on blood glucose and food intake are being elucidated within our laboratory.
Detailed description
According to the 2004 Canadian Community Health Survey, nearly two-thirds of Canadians are overweight or obese. Obesity is a major risk factor for the metabolic syndrome, which is linked to conditions such as type II diabetes. Dietary interventions that increase satiety (to promote weight loss) and maintain normal blood glucose levels are noninvasive and inexpensive compared to pharmacological strategies. Thus, it is important to identify types/sources of macronutrients that contribute to healthy body weight by increasing satiety and thereby reducing food intake. For instance, diets including pulses (legumes) have been linked with a lower risk of obesity/overweight.
Pulses are the edible seeds of legumes or pod-bearing plants including dry beans, yellow peas, lentils and chickpeas. They are inexpensive healthy foods high in protein and complex carbohydrates. Recently within our laboratory, we found that including 5 cups of pulses into the diet for 8 weeks was associated with decreased body weight, waist circumference and improved glycemic control. However, the mechanisms driving weight loss and improved glycemic control need further investigation. For instance, pulses may affect satiety, energy intake and blood glucose because of their high amounts of protein. Protein is known to be more satiating than carbohydrate and fat leading to a positive impact on long-term body weight maintenance. Protein from various animal and plant sources has also been shown to stimulate the release of satiety-related hormones like insulin, glucagon, glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK), peptide tyrosine tyrosine (PYY) and ghrelin.
The investigators recently investigated the independent dosage effects of pea protein (10 and 20 g) and pea fibre (10 and 20 g) on ad libitum food intake at 30 minutes and pre- (0-30 minutes) and post-meal (50-170 minutes) blood glucose response and subjective appetite in young men. Preliminary results indicate that increasing protein amounts (10 g versus 20 g) lead to decreased pre-meal blood glucose response and reduced food intake.
Food-grade proteins are also available intact and/or hydrolyzed (partially digested through a controlled enzymatic process). Hydrolyzed proteins are more easily digested and absorbed, eliciting a faster rise in plasma amino acids compared to intact proteins and different hormonal and metabolic responses between the two forms. As for pea protein, no data are available differentiating the effects of intact and hydrolyzed forms on these blood parameters and appetite in humans. Moreover, the presence of bioactive polypeptides may be affected by protein formulation (i.e. the polypeptides may be cleaved/inactivated in hydrolyzed pea protein).
Research is needed to determine whether the effect of pea protein differs on glycemic response and appetite both pre- and post-meal based on its form (intact versus hydrolyzed) and how it compares to other well-investigated proteins. This research is preliminary and may lead to future research in other population groups, including young women and overweight individuals. These results will encourage increased consumption of pulse fractions by providing a basis for the potential use of pea protein in the development of new functional foods aimed at preventing and managing obesity along with controlling blood glucose for diabetes management. Furthermore, results will show if pea protein is a comparable alternative to whey, which would be favorable for consumers shifting away from animal-derived proteins for health and/or environmental reasons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Intact Pea Protein (20 g) | Experimental | Other: Dietary intervention |
| Hydrolyzed Pea Protein (20 g) | Experimental | Other: Dietary intervention |
| Intact Whey Protein | Experimental | Other: Dietary intervention |
| Hydrolyzed Whey Protein | Experimental | Other: Dietary intervention |
| Water | Experimental | Other: Dietary intervention |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Non-smoking
- Aged 20-30 years
- Body mass index between 20 and 24.9 kg/m2
Key exclusion criteria (5 listed)
- Diabetes
- Gastrointestinal conditions
- Medication
- Lactose-intolerance or allergies to milk (standard breakfast provided)
- Breakfast skippers and those on an energy restricted diet
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 interventionDietary treatments with beverages | Other | Hydrolyzed Pea Protein (20 g), Hydrolyzed Whey Protein, Intact Pea Protein (20 g), Intact Whey Protein, Water |
Primary outcome
Food Intake
Time frame: 30 minutes
1 secondary outcome
Blood Glucose
Time frame: 0, 15, 30, 50, 65, 80, 95, 110, 140 and 170 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 5 May 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.
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 Phase 1 study testing Dietary intervention in people with Diabetes Prevention and Obesity Prevention, 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 4 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 May 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Food Intake (time frame: 30 minutes). 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 May 2011.