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Trial record 3 of 54 for:    barley

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
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Glenda Courtney-Martin, The Hospital for Sick Children

Brief Summary:
Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. Barley is an important cereal grain in the diet. The protein in barley is low in the essential amino acid lysine. Hence barley protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body. It is important to assess the effect of different cooking methods on the lysine availability of barley.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Barley Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meabolic Availabiliy of Barley
Healthy adult men
Dietary Supplement: Barley
Assessing the metabolic availability of lysine in barley.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: Mahroukh Rafii, BSc. 416-813-7454 mahroukh.rafii@sickkids.ca

Locations
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Canada, Ontario
The Hospital For Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Mahroukh Rafii, BSc.    416-813-7454    mahroukh.rafii@sickkids.ca   
Principal Investigator: Glenda Courtney-Martin, PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Glenda Courtney-Martin, PhD Associate Scientist

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Responsible Party: Glenda Courtney-Martin, Dietitian, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03907020     History of Changes
Other Study ID Numbers: 1000060245
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No