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Clinical Trials/NCT02587156
NCT02587156CompletedNot Applicable

Fate of Nutrient-Derived Amino Acids: Influence of Habituated Levels of Daily Dietary Protein Intake on Protein Utilization

Bispebjerg Hospital2 sites in 1 country12 target enrollmentStarted: October 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
2
Primary Endpoint
Abundance of milk protein-bound amino acid labels in blood protein.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 70 Years (Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Meal serving at high dietary protein

Experimental

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

Intervention: Meal serving at high dietary protein (Dietary Supplement)

Meal serving at high dietary protein

Experimental

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

Intervention: Meal serving (Dietary Supplement)

Meal serving at low dietary protein

Active Comparator

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

Intervention: Meal serving at low dietary protein (Dietary Supplement)

Meal serving at low dietary protein

Active Comparator

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

Intervention: Meal serving (Dietary Supplement)

Outcomes

Primary Outcomes

Abundance of milk protein-bound amino acid labels in blood protein.

Time Frame: Baseline to 240 min postprandial

Related to the trials conducted after 21 days of habituation to either high or low protein in the diet: After intake of milk proteins at time 0 (zero) the quantity of intrinsic labels D5-phe from whey and 15N-phe from casein will be measured in liver-synthesized blood protein at 240 min.

Secondary Outcomes

  • Leg phenylalanine rate of disappearance and appearance, net balance.(Baseline to 240 min postprandial)
  • Whole body phenylalanine rate of disappearance and appearance, net balance.(Baseline to 240 min postprandial)
  • The myofibrillar protein fractional synthesis rate(Baseline to 240 min postprandial)
  • Urea production.(Baseline to 240 min postprandial)
  • Fecal microbiota composition(Change from pre-intervention to 21 days and 22 days (21 intervention days habituation and the standardized trial meal on day 21))
  • Abundance of milk protein-bound amino acid labels in myofibrillar protein.(Baseline to 240 min postprandial)
  • Nitrogen and creatinine excreted in urine(21 days post intervention, 240 min postprandial and 24 hours post the day 21 trial day)
  • Adaptation of expression of proteins involved in muscle protein turnover(After 21 days of habituation to either a high or a low dietary protein intake.)
  • First pass splanchnic extraction of dietary protein-derived labeled phenylalanine.(Baseline to 240 min postprandial)
  • Response of expression of proteins involved in muscle protein turnover(Baseline, 60 min and 240 min postprandial)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Grith Højfeldt

MSc. Human Biology - PhD student

Bispebjerg Hospital

Study Sites (2)

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