NCT03674723

Brief Summary

The research study is being done so we can determine the quality of the protein present in Mung beans. 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… Mung beans as a food source contain low amounts of the essential amino acid methionine which makes its protein incomplete. The amino acids in Mung beans are also affected by cooking. Our objective is to determine the amount of methionine in Mung beans that the body can use. We will test Mung beans by studying them after cooking them in a stew, on their own and by combining the Mung bean stew with rice or wheat 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 Mung bean 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. Plant protein sources like Mung beans are important alternatives to animal protein in the diet. Plant protein consumption relative to animal protein can contribute to "enhance ecosystem resilience, and improved human health.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
5.5 years until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

September 14, 2018

Last Update Submit

May 23, 2025

Conditions

Keywords

HealthyMenAdultsMethionine

Outcome Measures

Primary Outcomes (1)

  • Metabolic availability of methionine in Mung beans

    Apply the IAAO method to determine the MA of methionine in Mung beans prepared by moist cooking method.

    2 years

Study Arms (1)

Arms

EXPERIMENTAL

Methionine bioavailability in Mung beans 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 freecookies and/or a Mung bean stew with or without rice or wheat, 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 Mung beans and 3 levels from Mung beans with rice or wheat.

Arms

Eligibility Criteria

Age18 Years - 49 Years
Sexmale(Gender-based eligibility)
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

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

  • Dr. Glenda Courtney-Martin

    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 4 levels of methionine provided as free amino acids, Mung beans, or Mung beans combined with rice or wheat for a total of 10 studies x 3 days per study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 17, 2018

Study Start

April 1, 2024

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations