Metabolic Availability in Older and Younger Men

NCT ID: NCT06332651

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2025-04-01

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.

Conditions

Ageing

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Black beans

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Black beans

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Milk

Intervention Type: OTHER

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

Sorghum

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Milk

Intervention Type: OTHER

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

Sorghum

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Sorghum

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

Intervention Type: OTHER

Other Intervention Names

Nutrition; Nutrition; Nutrition

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Marco Mensink

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wageningen University & Research

Wageningen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Fenna Hinssen, MSc

Role: primary

yoma@wur.nl

+031648043165

Karen Fransen, MSc

Role: backup

yoma@wur.nl

+031648043165

Other Identifiers

NL84684.091.23

Identifier Type: -

Identifier Source: org_study_id