Metabolic Availability of Lysine From Millet in Adult Men
|ClinicalTrials.gov Identifier: NCT03339167|
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : April 8, 2019
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, millet is the major cereal grain in the diet. The protein in millet is low in the essential amino acid lysine. Hence millet 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 millet 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 millet 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 millet||Not Applicable|
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 millet diets would have protein from cooked millet and 1 mixed meal would comprise of cooked millet 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Each subject will randomly receive 3 levels of lysine provided as free amino acids, millet, or millet combined with lentils for a total of 8 studies x 3 days per study.|
|Masking:||None (Open Label)|
|Official Title:||Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Millet Protein, in Young Adult Men|
|Actual Study Start Date :||November 11, 2017|
|Actual Primary Completion Date :||January 31, 2019|
|Actual Study Completion Date :||January 31, 2019|
Experimental: metabolic availability of lysine in millet
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 cooked millet with or without lentils, which will all be provided by the investigators.
Dietary Supplement: Metabolic availability of lysine in millet
Four levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from millet and 1 level from millet with lentils.
- Metabolic availability of Lysine in millet [ Time Frame: 2 years ]Apply the IAAO method to determine the Metabolic availability of Lysine in millet prepared by wet heat cooking method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339167
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Glenda Courtney-Martin, BSc, MSc, PhD||The Hospital for Sick Children|