NCT03907020

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable healthy

Timeline
13mo left

Started Dec 2025

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Dec 2025May 2027

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
6.7 years until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

April 5, 2019

Last Update Submit

May 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Meabolic Availabiliy of Barley

EXPERIMENTAL

Healthy adult men

Dietary Supplement: Barley

Interventions

BarleyDIETARY_SUPPLEMENT

Assessing the metabolic availability of lysine in barley.

Meabolic Availabiliy of Barley

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital For Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Study Officials

  • Glenda Courtney-Martin, PhD

    Associate Scientist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahroukh Rafii, BSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietitian

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 8, 2019

Study Start

December 30, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations