Metabolic Availability in Older and Younger Men (YOMA)

Metabolic Availability of Three Protein Sources in Older and Younger Men as Measured With the Indicator Amino Acid Oxidation Method

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.

Study Overview

• Status: Recruiting
• Conditions: Ageing
• Intervention / Treatment: Other: Black beans; Other: Milk; Other: Sorghum

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708PB
      • Recruiting
      • Wageningen University & Research
      • Contact: Fenna Hinssen, MSc; Phone Number: +031648043165; Email: yoma@wur.nl
      • Contact: Karen Fransen, MSc; Phone Number: +031648043165; Email: yoma@wur.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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:

• Glucose lowering drugs
• Proton pump inhibitors
• Laxatives

Habits that interfere with the study outcomes:

• Protein supplement use (current use or less than 2 weeks past use)
• Smoking
• Drug use
• Alcohol consumption >21 units/week and/or >4/day
• Following a weight-loss diet, medically prescribed diet or other diet with a low calorie intake or an unbalanced nutrient intake like a vegan or very low carbohydrate diet
• Moderate to high intense physical activity for more than 5 hours a week

Other:

• Self-reported allergy or intolerance to the tested products
• Weight loss of more than 3 kg in the 3 months prior to study screening
• Current participation in other research and <2 months prior participation in other research
• Not having a general practitioner
• Not willing to accept information-transfer concerning participation in the study , or information regarding his health to his general practitioner
• Working or doing an MSc- thesis at the department of Human Nutrition and Health at Wageningen University & Research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methionine in black beans in older men; 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; Black beans cooked and mashed and amino acid mixture as liquid drink to make methionine the limiting amino acid in the food consumed; Other Names: Nutrition
Experimental: Methionine in black beans in younger men; 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; Black beans cooked and mashed and amino acid mixture as liquid drink to make methionine the limiting amino acid in the food consumed; Other Names: Nutrition
Experimental: Lysine in milk or sorghum in older men; 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: Milk; Skimmed milk as liquid drink and amino acid mixture as liquid drink to make lysine the limiting amino acid in the food consumed; Other Names: Nutrition; Other: Sorghum; Sorghum cooked and mashed and amino acid mixture as liquid drink to make lysine the limiting amino acid in the food consumed; Other Names: Nutrition
Experimental: Lysine milk or sorghum in younger men; 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: Milk; Skimmed milk as liquid drink and amino acid mixture as liquid drink to make lysine the limiting amino acid in the food consumed; Other Names: Nutrition; Other: Sorghum; Sorghum cooked and mashed and amino acid mixture as liquid drink to make lysine the limiting amino acid in the food consumed; Other Names: Nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wageningen University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NL84684.091.23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No