Metabolic Availability of Lysine From Barley in Young Adult Men
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|ClinicalTrials.gov Identifier: NCT03907020|
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Barley||Not Applicable|
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
Experimental: Meabolic Availabiliy of Barley
Healthy adult men
Dietary Supplement: Barley
Assessing the metabolic availability of lysine in barley.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907020
|Contact: Mahroukh Rafii, BSc.||firstname.lastname@example.org|
|The Hospital For Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G1X8|
|Contact: Mahroukh Rafii, BSc. 416-813-7454 email@example.com|
|Principal Investigator: Glenda Courtney-Martin, PhD|
|Principal Investigator:||Glenda Courtney-Martin, PhD||Associate Scientist|