Metabolic Availability of Lysine From Barley in Young Adult Men

May 23, 2025 updated by: Glenda Courtney-Martin, The Hospital for Sick Children

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • The Hospital for Sick Children
        • Principal Investigator:
          • Glenda Courtney-Martin, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Glenda Courtney-Martin, PhD, Associate Scientist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

May 1, 2025

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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