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Metabolic Availability of Lysine From Wheat in Adult Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200652
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Glenda Courtney-Martin, The Hospital for Sick Children

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.


Condition or disease Intervention/treatment Phase
Healthy Men Dietary Supplement: Metabolic availability of lysine in wheat Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 21, 2017
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200652


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Glenda Courtney-Martin, BSc, MSc, PhD The Hospital for Sick Children
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Responsible Party: Glenda Courtney-Martin, Dietician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03200652    
Other Study ID Numbers: 1000056524
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glenda Courtney-Martin, The Hospital for Sick Children:
Lysine
Adult
Protein Quality