Clinical trial · Interventional
Metabolic Availability of Lysine From Wheat in Adult Men
Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Indian Wheat, in Healthy Young Adult Men
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. In many of those countries, wheat is the major cereal grain in the diet. The protein in wheat is low in the essential amino acid lysine. Hence wheat 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.The protein can be complemented by the addition of lentils to augment the low lysine content. However, lentils are prohibitively expensive in some developing countries. As the human population increases, the world faces the continuous challenge of maximizing a limited food supply. Protein quality (PQ) evaluation of wheat directly in humans would allow us to bridge the gap in knowledge between what is required and how best to provide.The information gathered from this project will provide the first direct experimental data on PQ of wheat protein in humans on which nutrition recommendations can be built.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
| Men | Multiple Endocrine Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metabolic availability of lysine in wheat | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- metabolic availability of lysine in wheat
- description
- Participants will be seen initially for pre-study assessment (2 hour). They will then be studied at 8 levels of lysine intake. Subjects will visit SickKid's Clinical Research Center a total of 9 times, with each visit being at least one week before the next. All 9 visits must be made within 6 months. Each set of experiment consists of a 3 day period. During the first 2 days (Adaptation Days) you will be expected to consume 4 meals per day consisting of a protein liquid drink and protein free-cookies and/or a baked wheat bread with or without lentils, which will all be provided by the investigators.
- interventionNames
- Dietary Supplement: Metabolic availability of lysine in wheat
Primary outcomes (1)
- measure
- Metabolic availability of Lysine in Indian Wheat
- timeFrame
- 2 years
- description
- Apply the IAAO method to determine the Metabolic availability of Lysine in Indian Wheat prepared by dry heat cooking method.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * Male, age 18 - 49 yrs * Healthy, with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes * Stable Body Weight * 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)
References
Publications (1)
- DERIVEDTul-Noor Z, Paoletti A, Fakiha A, Pencharz PB, Levesque CL, Ball RO, Elango R, Courtney-Martin G. Lysine from Whole Wheat Bread Consumed by Healthy Adult Males Has High Metabolic Availability When Assessed Using the Indicator Amino Acid Oxidation Method. J Nutr. 2025 Feb;155(2):476-482. doi: 10.1016/j.tjnut.2024.08.011. Epub 2024 Aug 18. PMID 39163973