Clinical trial NCT03200652: Metabolic Availability of Lysine From Wheat in Adult Men
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Men
Keywords: Lysine
Adult
Protein Quality
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-06-27
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: 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:

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

Eligibility criteria: 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)

Primary outcomes:
measure: Metabolic availability of Lysine in Indian Wheat
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Glenda Courtney-Martin, BSc, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: