Metabolic Availability in Older and Younger Men | NCT06332651

NCT06332651

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Milk Other: 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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Black beans	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 older men

Outcomes Module

Primary Outcomes

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

Eligibility Module

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

ID	Term
D009752	Nutritional Status
D008892	Milk

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D006304	Health Status