Clinical trial NCT02587156: Fate of Nutrient-Derived Amino Acids, FONDAA
Official title: Fate of Nutrient-Derived Amino Acids: Influence of Habituated Levels of Daily Dietary Protein Intake on Protein Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Utilization
Dietary Protein
Keywords: Required dietary protein
Amino acid
Splanchnic extraction
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 12
Sex: MALE
Minimum age (years): 65
Maximum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Abundance of milk protein-bound amino acid labels in blood protein.
timeFrame: Baseline to 240 min postprandial
Secondary outcomes:
measure: Abundance of milk protein-bound amino acid labels in myofibrillar protein.
timeFrame: Baseline to 240 min postprandial
measure: Leg phenylalanine rate of disappearance and appearance, net balance.
timeFrame: Baseline to 240 min postprandial
measure: First pass splanchnic extraction of dietary protein-derived labeled phenylalanine.
timeFrame: Baseline to 240 min postprandial
measure: Whole body phenylalanine rate of disappearance and appearance, net balance.
timeFrame: Baseline to 240 min postprandial
measure: The myofibrillar protein fractional synthesis rate
timeFrame: Baseline to 240 min postprandial
measure: Response of expression of proteins involved in muscle protein turnover
timeFrame: Baseline, 60 min and 240 min postprandial
measure: Urea production.
timeFrame: Baseline to 240 min postprandial
measure: Nitrogen and creatinine excreted in urine
timeFrame: 21 days post intervention, 240 min postprandial and 24 hours post the day 21 trial day
measure: Fecal microbiota composition
timeFrame: Change from pre-intervention to 21 days and 22 days (21 intervention days habituation and the standardized trial meal on day 21)
measure: Adaptation of expression of proteins involved in muscle protein turnover
timeFrame: After 21 days of habituation to either a high or a low dietary protein intake.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
Study officials:
affiliation: Bispebjerg Hospital
name: Grith Højfeldt, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Lars Holm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hojfeldt G, Bulow J, Agergaard J, Asmar A, Schjerling P, Simonsen L, Bulow J, van Hall G, Holm L. Impact of habituated dietary protein intake on fasting and postprandial whole-body protein turnover and splanchnic amino acid metabolism in elderly men: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Dec 10;112(6):1468-1484. doi: 10.1093/ajcn/nqaa201.