Metabolic Availability of Lysine From Barley in Young Adult Men

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03907020
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
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9
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Study Details

Study Description

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
  • Dietary Supplement: Barley
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
7 participants
Allocation:
N/A
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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Meabolic Availabiliy of Barley

Healthy adult men

Dietary Supplement: Barley
Assessing the metabolic availability of lysine in barley.

Outcome Measures

Primary Outcome Measures

  1. Phenylalanine Oxidation [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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital For Sick Children Toronto Ontario Canada M5G1X8

Sponsors and Collaborators

  • The Hospital for Sick Children
  • Canadian Institutes of Health Research (CIHR)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Glenda Courtney-Martin, Dietitian, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT03907020
Other Study ID Numbers:
  • 1000060245
First Posted:
Apr 8, 2019
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 21, 2021