NCT03110913

Brief Summary

The research study is being done so we can determine the quality of the protein present in Canadian 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… Lentils as a food source contain low amounts of the essential amino acid methionine which makes its protein incomplete. The amino acids in lentils are also affected by cooking. Our objective is to determine the amount of methionine in lentils that the body can use. We will test lentils by studying them after cooking them in a stew, on their own and by combining the lentil stew with rice in a mixed meal to make a more complete protein. 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 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 directly applicable to humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant protein sources like lentils are important alternatives 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
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2017

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

April 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

April 7, 2017

Last Update Submit

October 10, 2019

Conditions

Keywords

HealthyMenAdultsMethionine

Outcome Measures

Primary Outcomes (1)

  • Metabolic availability of methionine in Canadian lentils

    Apply the IAAO method to determine the MA of methionine in Canadian grown lentils prepared by moist cooking method.

    2 years

Study Arms (1)

Methionine bioavailability in lentils

EXPERIMENTAL

Participants will be seen initially for pre-study assessment (3 hour). They will then be studied for up to 10 times. levels of phenylalanine intake (7 Study periods). You could be expected to participate in up to 10 different sets of experiments which will take 11 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 free-cookies and/or a lentil stew with or without rice, which will be provided by the investigators

Other: dietary intakes

Interventions

Four levels of methionine intakes will be provided by the reference protein drinks, 3 levels of methionine from lentils and 3 levels from lentils with rice.

Methionine bioavailability in lentils

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 (1)

  • Rafii M, Pencharz PB, Boileau K, Ball RO, Tomlinson C, Elango R, Courtney-Martin G. Metabolic Availability of Methionine Assessed Using Indicator Amino Acid Oxidation Method, Is Greater when Cooked Lentils and Steamed Rice Are Combined in the Diet of Healthy Young Men. J Nutr. 2022 Jun 9;152(6):1467-1475. doi: 10.1093/jn/nxac049.

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Each subject will randomly receive 4 levels of methionine provided as free amino acids, lentils, or lentils combined with rice for a total of 10 studies x 3 days per study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Investigator

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 12, 2017

Study Start

April 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations