Metabolic Availability of Lysine From Barley in Young Adult Men

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03907020
• Other study ID #: 1000060245
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2025
• Est. completion date: May 1, 2027

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: Mahroukh Rafii, BSc.
• Phone: 416-813-7454
• Email: mahroukh.rafii[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7
• Est. completion date: May 1, 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital For Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phenylalanine Oxidation	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