Clinical trial NCT06332651: Metabolic Availability in Older and Younger Men
Official title: Metabolic Availability of Three Protein Sources in Older and Younger Men as Measured With the Indicator Amino Acid Oxidation Method
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ageing
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Metabolic availability of methionine in black beans and lysine in milk and sorghum measured with the indicator amino acid oxidation method.
timeFrame: 1 measurement to be calculated from repeated measurements on several test days separated by 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
state: Gelderland
Study officials:
References: