NCT06332651

Brief Summary

The main goal of this study is to determine the metabolic availability of methionine in black beans, lysine in sorghum and lysine in milk using the indicator amino acid oxidation method both in older and in younger men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 19, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

May 7, 2026

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

December 19, 2023

Last Update Submit

May 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Metabolic availability of methionine in black beans and lysine in milk and sorghum measured with the indicator amino acid oxidation method.

    Indicator amino acid oxidation method is used to measure metabolic availability of the limiting amino acid by measuring the oxidation of the 13C-labelled indicator amino acid in expired breath as 13CO2 when giving different levels of the limiting amino acid. Methionine metabolic availability will be assessed in black beans and lysine metabolic availability in milk and sorghum.

    1 measurement to be calculated from repeated measurements on several test days separated by 1 week

Study Arms (4)

Methionine in black beans in older men

EXPERIMENTAL

This group of 7 participants will have 3 test days where they consume black beans with 3 different levels of methionine and they will have 4 test days where they consume the reference amino acid mixture with 4 different levels of methionine.

Other: Black beans

Methionine in black beans in younger men

EXPERIMENTAL

This group of 7 participants will have 3 test days where they consume black beans with 3 different levels of methionine and they will have 4 test days where they consume the reference amino acid mixture with 4 different levels of methionine.

Other: Black beans

Lysine in milk or sorghum in older men

EXPERIMENTAL

This group of 7 participants will have 3 test days where they consume milk with 3 different levels of lysine, they will have 3 test days where they consume sorghum with 3 different levels of lysine and they will have 4 test days where they consume the reference amino acid mixture with 4 different levels of lysine.

Other: MilkOther: Sorghum

Lysine milk or sorghum in younger men

EXPERIMENTAL

This group of 7 participants will have 3 test days where they consume milk with 3 different levels of lysine, they will have 3 test days where they consume sorghum with 3 different levels of lysine and they will have 4 test days where they consume the reference amino acid mixture with 4 different levels of lysine.

Other: MilkOther: Sorghum

Interventions

Black beans cooked and mashed and amino acid mixture as liquid drink to make methionine the limiting amino acid in the food consumed

Also known as: Nutrition
Methionine in black beans in older menMethionine in black beans in younger men
MilkOTHER

Skimmed milk as liquid drink and amino acid mixture as liquid drink to make lysine the limiting amino acid in the food consumed

Also known as: Nutrition
Lysine in milk or sorghum in older menLysine milk or sorghum in younger men
SorghumOTHER

Sorghum cooked and mashed and amino acid mixture as liquid drink to make lysine the limiting amino acid in the food consumed

Also known as: Nutrition
Lysine in milk or sorghum in older menLysine milk or sorghum in younger men

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gender: Male Age: 20-35 years or 65-80 years Body Mass Index (BMI): 18.5 - 30.0 kg/m2 Healthy as assessed with a questionnaire Regular and normal eating habits as assessed with a Food Frequency Questionnaire (FFQ) Willing to comply with study procedures and use of data Having given written informed consent

You may not qualify if:

  • Chronic disease, for example:
  • Diabetes mellitus / being treated for high blood glucose
  • Severe cardiovascular disease (exception: hypertension)
  • Hepatic disease (e.g. hepatitis)
  • Renal disease
  • Cancer
  • Bowel disease (e.g. inflammatory bowel disease, ulcers, bleeding)
  • Pancreatitis
  • History of medical or surgical events that may affect GI function, and the study outcomes or disease risk for participants, for example:
  • Bariatric surgery
  • Gastrointestinal tract surgery
  • Digestive tract disorder
  • Chewing problems
  • History of deep venous thrombosis without anti-coagulation medication
  • Medicine use that interferes with, protein metabolism, GI function and the study outcomes, for example:
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, 6708PB, Netherlands

Location

MeSH Terms

Interventions

Nutritional StatusMilk

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsBeveragesDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: It is a parallel intervention study. The intervention does not involve a drug or biologic product, however does involve an adaptation diet and a diet with measured amino acids dissolved in water, during the test day. We investigate the amino acid metabolic availability using the IAAO method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 19, 2023

First Posted

March 27, 2024

Study Start

February 19, 2024

Primary Completion

June 30, 2025

Study Completion

July 15, 2025

Last Updated

May 7, 2026

Record last verified: 2025-07

Locations