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Completed

NCT Number: NCT03200652

Metabolic Availability of Lysine From Wheat in Adult Men

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.

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Key information

Conditions

Healthy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Men Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

Each subject will be part of 8 different experimental diets, and randomly assigned to one of the diets every time.

4 reference diet would be based on egg protein composition, 3 wheat diets would have protein from baked wheat bread and 1 mixed meal would comprise of baked wheat bread and lentils.

Each experimental diet will be studied over 3 days: 2 adaptation and 1 study day. The 2 adaptation meals would be consumed at home. On the study day 3, following a 12-h overnight fast, subjects will come to the research unit at The Hospital for Sick Children, Toronto, ON for a period of 7.5 h and consume the diet as 9 hourly meals. The first 3 meals would be consumed at home.

For the duration of all experiments, subjects will consume a daily multivitamin supplement to ensure adequate vitamin intake.

Measurements:

  • Resting energy expenditure (REE) will be measured by open-circuit indirect calorimetry
  • Body composition (fat and fat free mass) will be measured by BIA and Skin Fold.
  • Breath samples will be collected after the 4th and 7th meals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Metabolic availability of Lysine in Indian Wheat

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Indian Wheat, in Healthy Young Adult Men

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2017
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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