Metabolic Availability of Lysine From Sorghum in Adult Men

NCT ID: NCT03411005

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2018-11-22

Brief Summary

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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, sorghum is the major cereal grain in the diet. The protein in sorghum is low in the essential amino acid lysine. Hence sorghum 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 sorghum 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 sorghum protein in humans on which nutrition recommendations can be built.

Detailed Description

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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 sorghum diets would have protein from cooked sorghum and 1 mixed meal would comprise of cooked sorghum 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.

Conditions

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Healthy Men

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each subject will randomly receive 3 levels of lysine provided as free amino acids, sorghum, or sorghum combined with lentils for a total of 8 studies x 3 days per study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Metabolic availability of lysine in Sorghum

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 sorghum with or without lentils, which will all be provided by the investigators.

Group Type EXPERIMENTAL

Metabolic availability of lysine in sorghum

Intervention Type DIETARY_SUPPLEMENT

Four levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from sorghum and 1 level from sorghum with lentils.

Interventions

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Metabolic availability of lysine in sorghum

Four levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from sorghum and 1 level from sorghum with lentils.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Glenda Courtney-Martin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Glenda Courtney-Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Paoletti A, Fakiha A, Tul-Noor Z, Pencharz PB, Levesque CL, Ball RO, Kong D, Elango R, Courtney-Martin G. Bioavailable Lysine Assessed Using the Indicator Amino Acid Oxidation Method in Healthy Young Males is High when Sorghum is Cooked by a Moist Cooking Method. J Nutr. 2022 Mar 3;152(3):770-778. doi: 10.1093/jn/nxab410.

Reference Type DERIVED
PMID: 34871427 (View on PubMed)

Other Identifiers

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1000058988

Identifier Type: -

Identifier Source: org_study_id

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