NCT03674736

Brief Summary

The research study is being done so we can determine the quality of the protein present in Rice, Wheat, Chickpeas and Lentils. Amino acids are the building blocks of protein and protein quality is determined by the amount of amino acids present and by their bioavailability (their absorption and use by the body). Some amino acids are essential which means they must be obtained from the diet. If any one of the essential amino acids is missing in the diet, the body cannot make proteins that are used to repair tissue build bone, teeth, etc… Rice, Wheat, Chickpeas and Lentils as a food source contain low amounts of the essential amino acid methionine (Chickpeas and Lentils) and lysine (Rice and Wheat) which makes its protein incomplete. The amino acids in Rice, Wheat, Chickpeas and Lentils are also affected by cooking. Our objective is to determine the amount of methionine in Rice and Wheat and the amount of lysine in Chickpeas and Lentils that the body can use. This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of Rice, Wheat, Chickpeas and Lentils as a major protein source in the diet. Previously the quality of dietary protein for human consumption was studied in animals. This study is being done in humans because studies in animals are not always directly applicable to humans. Plant protein sources like rice, wheat, chickpeas and lentils are important protein sources shown to "enhance ecosystem resilience, and improve human health.

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 healthy

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable healthy

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

Study Start

First participant enrolled

September 1, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

September 14, 2018

Last Update Submit

May 31, 2023

Conditions

Keywords

HealthyMenAdultsMethionineLysine

Outcome Measures

Primary Outcomes (4)

  • Metabolic availability of Methionine in Rice Apply the IAAO method to determine the MA of methionine in Canadian grown lentils prepared by moist cooking method.

    Apply the IAAO method to determine the MA of methionine in rice method.

    2 years

  • Metabolic availability of Methionine in Wheat

    Apply the IAAO method to determine the MA of methionine in wheat bread

    2 years

  • Metabolic availability of Lysine in Chickpeas

    Apply the IAAO method to determine the MA of lysine in chickpeas

    2 years

  • Metabolic availability of Lysine in Lentils

    Apply the IAAO method to determine the MA of lysine in Canadian grown lentils

    2 years

Study Arms (4)

Methionine bioavailability in Rice

EXPERIMENTAL

Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Rice which will be provided by the investigators

Dietary Supplement: Dietary Intakes

Lysine bioavailability in Chickpeas

EXPERIMENTAL

Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Chickpeas which will be provided by the investigators

Dietary Supplement: Dietary Intakes

Methionine bioavailability in Wheat

EXPERIMENTAL

Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Wheat bread which will be provided by the investigators

Dietary Supplement: Dietary Intakes

Lysine bioavailability in Lentils

EXPERIMENTAL

Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 7 times. You could be expected to participate in up to 7 different sets of experiments which will take 8 weeks to 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 freecookies and/or Lentils which will be provided by the investigators

Dietary Supplement: Dietary Intakes

Interventions

Dietary IntakesDIETARY_SUPPLEMENT

Four levels of methionine or lysine intakes will be provided by the reference protein drinks, 3 levels of methionine from rice and wheat bread and 3 levels of lysine from chickpeas and lentils

Lysine bioavailability in ChickpeasLysine bioavailability in LentilsMethionine bioavailability in RiceMethionine bioavailability in Wheat

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 (no more than 5 lb weight loss or gain in the past 3 months) 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 (3)

  • Tul-Noor Z, Paoletti A, Fakiha A, Pencharz PB, Levesque CL, Ball RO, Elango R, Courtney-Martin G. Lysine from Whole Wheat Bread Consumed by Healthy Adult Males Has High Metabolic Availability When Assessed Using the Indicator Amino Acid Oxidation Method. J Nutr. 2025 Feb;155(2):476-482. doi: 10.1016/j.tjnut.2024.08.011. Epub 2024 Aug 18.

  • Fakiha A, Tul-Noor Z, Paoletti A, Pencharz PB, Ball RO, Levesque CL, Elango R, Courtney-Martin G. Bioavailable Lysine, Assessed in Healthy Young Men Using Indicator Amino Acid Oxidation, is Greater when Cooked Millet and Stewed Canadian Lentils are Combined. J Nutr. 2020 Oct 12;150(10):2729-2737. doi: 10.1093/jn/nxaa227.

  • Rafii M, Pencharz PB, Ball RO, Tomlinson C, Elango R, Courtney-Martin G. Bioavailable Methionine Assessed Using the Indicator Amino Acid Oxidation Method Is Greater When Cooked Chickpeas and Steamed Rice Are Combined in Healthy Young Men. J Nutr. 2020 Jul 1;150(7):1834-1844. doi: 10.1093/jn/nxaa086.

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Eating

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Glenda Courtney-Martin

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Each subject will randomly receive 4 levels of methionine or lysine provided as free amino acids, Rice, Wheat, Chickpeas or Lentils for a total of 7 studies x 3 days per study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Investigator

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 17, 2018

Study Start

September 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations