- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03339154
Metabolic Availability of Methionine From Chickpeas in Adult Men
Study Title: Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Methionine From Canadian Lentils, in Healthy Young Adult Men
The research study is being done so we can determine the quality of the protein present in Canadian chickpeas. Amino acids are the building blocks of protein and protein quality is determined by the amount of amino acids present and by their bioavailability (their absorption and use by the body). Some amino acids are essential which means they must be obtained from the diet. If any one of the essential amino acids is missing in the diet, the body cannot make proteins that are used to repair tissue build bone, teeth, etc…Chickpeas as a food source contain low amounts of the essential amino acid methionine which makes its protein incomplete. The amino acids in chickpeas are also affected by cooking. Our objective is to determine the amount of methionine in chickpeas that the body can use. We will test chickpeas by studying them after cooking them, on their own and by combining the chickpeas with rice in a mixed meal to make a more complete protein.
This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of chickpeas as a major protein source in the diet.
Previously the quality of dietary protein for human consumption was studied in animals. This study is being done in humans because studies in animals are not directly applicable to humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant protein sources like chickpeas are important alternatives shown to "enhance ecosystem resilience, and improve human health.
Study Overview
Detailed Description
If you agree to take part in this study, you will receive 3 different amounts of chickpeas which will contain different amounts of the essential amino acid methionine as well as 3 different amount of chickpeas complemented with rice. The chickpeas will be cooked on its own or served with the rice. The quality of the protein in the chickpeas will be compared to the quality of a reference protein (egg protein) by giving you 4 reference diets containing amino acids make up like the amino acids in egg protein. The amount of chickpeas you receive will be provided in a random order.
Breath samples will be collected after the 4th meal in 15 min intervals for 1 hour. Breath collection will resume again two and a half hours after the 5th meal every 15 minutes until 30 minutes after the last meal. A total of 52 breath samples will be collected during each of the 3rd study day.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- The Hospital for Sick Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male, age 18 - 49 yrs, Healthy with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes, Stable Body Weight (no more than 5 lb weight loss or gain in the past 3 months) Not on any medications that could affect protein or amino acid metabolism e.g. steroids
Exclusion Criteria:
- Unwillingness to participate or unable to tolerate the diet Recent history of weight loss within the last 3 months or on a weight reducing diet Inability to tolerate study diets (ex. Allergy to ingredients).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Methionine bioavailability in chickpeas
Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 10 times. levels of phenylalanine intake (7 Study periods). You could be expected to participate in up to 10 different sets of experiments which will take 11 weeks to 6 months. Each set of experiment consists of a 3 day period. During the first 2 days (Adaptation Days) you will be expected to consume 4 meals per day consisting of a protein liquid drink and protein freecookies and/or chickpeas with or without rice, which will be provided by the investigators |
Four levels of methionine intakes will be provided by the reference protein drinks, 3 levels of methionine from chickpeas and 3 levels from chickpeas with rice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic availability of methionine in Canadian chickpeas
Time Frame: 2 years
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Apply the IAAO method to determine the MA of methionine in Canadian grown chickpeas prepared by moist cooking method.
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2 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1000056462
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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