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Completed

NCT Number: NCT03870425

Distribution of Nutrient Derived Amino Acids

The project examines over several days how the distribution pattern of dietary protein stimulate and affect the protein turnover of important proteins in the aging perspective, such as skeletal muscle proteins.

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Key information

Conditions

Muscle Mass Atrophy Diet Modification Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Protein Breakdown Protein Intake Protein Synthesis Sarcopenia Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine Copenhagen

Copenhagen, DK-2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women
  • Between 65-80 years of age

Exclusion criteria

  • BMI above 30
  • Smokers
  • Vegetarians
  • Diabetes or other metabolic diseases
  • Medical treatment which affects protein turnover
  • Gastro-intestinal diseases, reduced kidney or liver function, or chronic inflammation diseases
  • Elevated blood-pressure or signs of atherosclerosis
  • More than 5 hours of regular exercise each week

Treatment and study plan

Distribution pattern of dietary proteins (minced meat)

Other

Study effect of an even or skewed distribution pattern of dietary protein

Primary outcomes

  1. Muscle protein synthesis

    Time frame: 3 days

    Myofibrillar FSR measured by deuterated water technique, by which deuterium labeled alanine incorporation into myofibrillar muscle protein synthesis can be measured.

  2. Net protein balance

    Time frame: 10 hours

    Whole body net protein balance measured during 10 hours acute study. Measured by the application of stable amino acid labeled phenylalanine and tyrosine tracers, by which the protein synthesis, phenylalanine oxidation and protein breakdown can be calculated.

Secondary outcomes

  1. D5-phenylalanine incorporation

    Time frame: 3 days

    D5-phenylalanine incorporation into myofibrillar proteins. Dietary meat proteins are intrinsically labeled with D5-phenylalanine

  2. Muscle protein synthesis

    Time frame: 10 hours

    Myofibrillar protein synthesis (%/hour) measured during 10 hours of the acute study. Calculated from the difference in D8-phenylalanine incorporation from the muscle biopsies taken at 2 hours and 12 hours into the stable amino acid tracer infusion.

  3. Protein synthesis

    Time frame: 10 hours

    Whole body protein synthesis (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.

  4. Protein breakdown

    Time frame: 10 hours

    Whole body protein breakdown (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.

  5. Phenylalanine oxidation

    Time frame: 10 hours

    Phenylalanine oxidation measured during acute study

  6. D5-phenylalanine appearance

    Time frame: 12 hours

    Plasma D5-phenylalanine enrichment after intake of D5-phenylalanine intrinsically labelled meat proteins

  7. Signaling pathways in skeletal muscle

    Time frame: 10 hours

    Intracellular signaling pathways related to protein turnover. Measured by Western blotting technique from the muscle tissue biopsies taken at 2 hours and 12 hours into the acute study.

  8. Plasma insulin

    Time frame: 12 hours

    Plasma insulin concentration during acute study

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Distribution of Nutrient Derived Amino Acids and Anabolic Effect in Healthy Elderly Individuals

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Mar 12, 2019
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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