Metabolic Availability in Older and Younger Men

Ageing Clinical Trial

— YOMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332651
• Other study ID #: NL84684.091.23
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: April 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ageing

Intervention

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

Locations

Country	Name	City	State
Netherlands	Wageningen University & Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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