Back to resultsDistribution of Nutrient Derived Amino Acids
Primary Purpose
Muscle Mass, Protein Intake, Diet Modification
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Distribution pattern of dietary proteins (minced meat)
Sponsored by
About this trial
This is an interventional prevention trial for Muscle Mass focused on measuring Dietary protein, Sarcopenia, Protein turnover, Muscle protein
Eligibility Criteria
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
Sites / Locations
- Institute of Sports Medicine Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
MINCED-SKEWED
MINCED-EVEN
Arm Description
Minced meat administered with a skewed protein distribution pattern
Minced meat administered with an even protein distribution pattern
Outcomes
Primary Outcome Measures
Muscle protein synthesis
Myofibrillar FSR measured by deuterated water technique, by which deuterium labeled alanine incorporation into myofibrillar muscle protein synthesis can be measured.
Net protein balance
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 Outcome Measures
D5-phenylalanine incorporation
D5-phenylalanine incorporation into myofibrillar proteins. Dietary meat proteins are intrinsically labeled with D5-phenylalanine
Muscle protein synthesis
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.
Protein synthesis
Whole body protein synthesis (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.
Protein breakdown
Whole body protein breakdown (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.
Phenylalanine oxidation
Phenylalanine oxidation measured during acute study
D5-phenylalanine appearance
Plasma D5-phenylalanine enrichment after intake of D5-phenylalanine intrinsically labelled meat proteins
Signaling pathways in skeletal muscle
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.
Plasma insulin
Plasma insulin concentration during acute study
Full Information
NCT ID
NCT03870425
First Posted
January 18, 2019
Last Updated
November 18, 2022
Sponsor
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03870425
Brief Title
Distribution of Nutrient Derived Amino Acids
Official Title
Distribution of Nutrient Derived Amino Acids and Anabolic Effect in Healthy Elderly Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Mass, Protein Intake, Diet Modification, Protein Synthesis, Protein Breakdown, Sarcopenia
Keywords
Dietary protein, Sarcopenia, Protein turnover, Muscle protein
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MINCED-SKEWED
Arm Type
Placebo Comparator
Arm Description
Minced meat administered with a skewed protein distribution pattern
Arm Title
MINCED-EVEN
Arm Type
Experimental
Arm Description
Minced meat administered with an even protein distribution pattern
Intervention Type
Other
Intervention Name(s)
Distribution pattern of dietary proteins (minced meat)
Intervention Description
Study effect of an even or skewed distribution pattern of dietary protein
Primary Outcome Measure Information:
Title
Muscle protein synthesis
Description
Myofibrillar FSR measured by deuterated water technique, by which deuterium labeled alanine incorporation into myofibrillar muscle protein synthesis can be measured.
Time Frame
3 days
Title
Net protein balance
Description
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.
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
D5-phenylalanine incorporation
Description
D5-phenylalanine incorporation into myofibrillar proteins. Dietary meat proteins are intrinsically labeled with D5-phenylalanine
Time Frame
3 days
Title
Muscle protein synthesis
Description
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.
Time Frame
10 hours
Title
Protein synthesis
Description
Whole body protein synthesis (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.
Time Frame
10 hours
Title
Protein breakdown
Description
Whole body protein breakdown (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.
Time Frame
10 hours
Title
Phenylalanine oxidation
Description
Phenylalanine oxidation measured during acute study
Time Frame
10 hours
Title
D5-phenylalanine appearance
Description
Plasma D5-phenylalanine enrichment after intake of D5-phenylalanine intrinsically labelled meat proteins
Time Frame
12 hours
Title
Signaling pathways in skeletal muscle
Description
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.
Time Frame
10 hours
Title
Plasma insulin
Description
Plasma insulin concentration during acute study
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Sports Medicine Copenhagen
City
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Distribution of Nutrient Derived Amino Acids
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