Metabolic Availability of Lysine From Wheat in Adult Men

NCT03200652 | Completed

• 1 other identifier: 1000056524
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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. 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

Healthy; Men

Keywords

Lysine; Adult; Protein Quality

Outcome Measures

Primary Outcomes (1)

• Metabolic availability of Lysine in Indian Wheat

  Apply the IAAO method to determine the Metabolic availability of Lysine in Indian Wheat prepared by dry heat cooking method.

  2 years

Study Arms (1)

metabolic availability of lysine in wheat

EXPERIMENTAL

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.

Dietary Supplement: Metabolic availability of lysine in wheat

Interventions

Metabolic availability of lysine in wheat DIETARY_SUPPLEMENT

Four levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from wheat and 1 level from wheat with lentils.

metabolic availability of lysine in wheat

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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)

Sponsors & Collaborators

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

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Tul-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 DERIVED

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Flour

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Glenda Courtney-Martin, BSc, MSc, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

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: Dietician

Model Details: Each subject will randomly receive 3 levels of lysine provided as free amino acids, wheat, or wheat combined with lentils for a total of 8 studies x 3 days per study.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 27, 2017
• Study Start: June 21, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)