- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01298154
Effects of Intact and Hydrolyzed Pea Protein on Food Intake, Glycemic Response and Subjective Appetite
The Effects of Intact and Hydrolyzed Yellow Pea Protein on Food Intake, Glycemic Response, and Subjective Appetite in Healthy Young Men.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 3E2
- University of Toronto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
- Non-smoking
- Aged 20-30 years
- Body mass index between 20 and 24.9 kg/m2
Exclusion Criteria:
- Diabetes
- Gastrointestinal conditions
- Medication
- Lactose-intolerance or allergies to milk (standard breakfast provided)
- Breakfast skippers and those on an energy restricted diet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intact Pea Protein (20 g)
|
Dietary treatments with beverages
|
Experimental: Hydrolyzed Pea Protein (20 g)
|
Dietary treatments with beverages
|
Experimental: Intact Whey Protein
|
Dietary treatments with beverages
|
Experimental: Hydrolyzed Whey Protein
|
Dietary treatments with beverages
|
Experimental: Water
|
Dietary treatments with beverages
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Food Intake
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Glucose
Time Frame: 0, 15, 30, 50, 65, 80, 95, 110, 140 and 170 minutes
|
0, 15, 30, 50, 65, 80, 95, 110, 140 and 170 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harvey Anderson, PhD, University of Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PureNet_23878
- peaprotein_486233 (Other Grant/Funding Number: Agriculture & Agri-Food Canada)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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