Fate of Nutrient-Derived Amino Acids, FONDAA

Bispebjerg Hospital

Status: Completed

Conditions: Protein Utilization; Dietary Protein

Treatments: Dietary Supplement: Meal serving; Dietary Supplement: Meal serving at low dietary protein; Dietary Supplement: Meal serving at high dietary protein

Study type: Interventional

Funder types: Other

Identifiers

NCT02587156

BBH122

Details and patient eligibility

About

12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. At the end of each habituation period, the investigators will measure the appearance of labelled amino acids from milk proteins.

Enrollment: 12 patients

Sex: Male

Ages: 65 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

• Hyperlipidemia
• Hypertension

Inclusion Criteria:

• Males age 65-70
• Independently dwelling
• Without any major health issues (blood pressure, cholesterol and lipid profile will be measured and evaluated by a physician)
• Non-diabetic
• No organ disease
• No back pain
• Not regularly take any prescription drugs or dietary supplements, which can influence muscle protein synthesis
• Alcohol intake below 21 units pr. week
• No known arthrosclerosis

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

Meal serving at high dietary protein

Experimental group

Description:

Test the handling of meal-served protein when habituated to high dietary protein at an amount above 1.5 g protein/kg/day

Treatment:

Dietary Supplement: Meal serving at high dietary protein

Dietary Supplement: Meal serving

Meal serving at low dietary protein

Active Comparator group

Description:

Test the handling of meal-served protein when habituated to high dietary protein at an amount below 0.8 g protein/kg/day

Treatment:

Dietary Supplement: Meal serving

Dietary Supplement: Meal serving at low dietary protein