- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907020
Metabolic Availability of Lysine From Barley in Young Adult Men
Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Barley and Oatmeal Protein, in Young Adult Men
Study Overview
Detailed Description
Each subjects will receive each of up to 10 experimental diets for the Barley Study (4 reference protein diets providing, 3 Barley diets using dry cooking method, and 3 Barley diets using moist heat cooking method) in random order over a series of up to 10 experimental periods. The reference protein diet will be patterned after the AA pattern of egg protein using crystalline AA as the protein source. Three of the 4 lysine levels will be replaced by lysine provided in Barley each cooked using two different cooking methods ( dry and moist-heat).Each experiment will be conducted over 3 days.
Adaptation days:
During days 1 and 2 the subjects will be adapted to the level of lysine being studied, consuming the same diet as they will receive on day 3 (IAAO study day). The adaptation diet will be consumed as 4 equal meals.Meals will be divided into 4 equal parts to be spread evenly throughout the day and consumed in their usual environment on their usual activities of daily living.
IAAO study day/isotope delivery and sample collection day:
On the oxidation study day 3, following a 12-h overnight fast, subjects will come to the Hospital for Sick Children, Toronto, ON for a period of 5.5 h. On the oxidation study day, the diet is consumed as 9 iso-nitrogenous and iso-energetic hourly meals. Between meals, subjects are allowed to rest on bed, watch television or use a computer. Study days for each participant will be separated by ≥ 1 week. For the duration of all experiments, subjects will consume a daily multivitamin (Centrum Forte, Whitehall Robins) and 500 mg choline supplement (Nature's Way or equivalent), to ensure adequate vitamin intake. The multi vitamin supplement is provided to ensure that no vitamin cofactors are limiting in the diet which could alter metabolic pathways and functioning.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahroukh Rafii, BSc.
- Phone Number: 416-813-7454
- Email: mahroukh.rafii@sickkids.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- The Hospital for Sick Children
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Principal Investigator:
- Glenda Courtney-Martin, PhD
-
Contact:
- Mahroukh Rafii, BSc.
- Phone Number: 416-813-7454
- Email: mahroukh.rafii@sickkids.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male, age 18 - 40 years, Healthy with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes,
- Stable Body Weight (±0 to 5lb weight gain or loss in the last 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: Meabolic Availabiliy of Barley
Healthy adult men
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Assessing the metabolic availability of lysine in barley.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenylalanine Oxidation
Time Frame: 8 hrs
|
Breath samples will be collected from each subject on each study day and the 13C enrichment measured by mass spectrometry.
This will be plotted against phenylalanine intake in the reference and barley diets to determine the amount of lysine available in barley.
|
8 hrs
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Glenda Courtney-Martin, PhD, Associate Scientist
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 1000060245
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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