NCT03411005

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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2018

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

January 13, 2018

Last Update Submit

April 5, 2019

Conditions

Keywords

Lysine, Adult, Protein Quality

Outcome Measures

Primary Outcomes (1)

  • Assessment of the protein quality of Sorghum by determining the Metabolic availability of Lysine.

    The MA of lysine in sorghum will be studied using the IAAO technique with L-(1-13C) phenylalanine as the indicator. In order to determine the MA of lysine, four levels of lysine will be tested; (5, 8, 12, 15 mg/kg/d which represent 13, 21, 32 and 40% of the lysine requirement for adults (37 mg/kg/d)) in five healthy adult men in a repeated measures design. Each subject will participate in 8 experiments: 4 lysine intakes as L-lysine from crystalline amino acid, 3 intakes of lysine from sorghum prepared by moist cooking and 1 experiment for dietary complementation with lentils. The MA of lysine will be estimated by comparing the IAAO response to varying intakes of Lysine in cooked sorghum compared with the IAAO response to lysine intakes in the reference protein (crystalline amino acid mixture patterned after egg protein) using the slope ratio method.

    2 years

Study Arms (1)

Metabolic availability of lysine in Sorghum

EXPERIMENTAL

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.

Dietary Supplement: Metabolic availability of lysine in sorghum

Interventions

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.

Metabolic availability of lysine in Sorghum

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

  • 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.

Study Officials

  • Glenda Courtney-Martin, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2018

First Posted

January 25, 2018

Study Start

February 15, 2018

Primary Completion

September 1, 2018

Study Completion

November 22, 2018

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations