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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Men
• Intervention / Treatment: Dietary supplement: Metabolic availability of lysine in wheat

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: metabolic availability of lysine in wheat; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Glenda Courtney-Martin, BSc, MSc, PhD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Adult; Lysine; Protein Quality
• Other Study ID Numbers: 1000056524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No