Distribution of Nutrient Derived Amino Acids
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedStudy Start
First participant enrolled
April 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedNovember 21, 2022
November 1, 2022
1.2 years
January 18, 2019
November 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Muscle protein synthesis
Myofibrillar FSR measured by deuterated water technique, by which deuterium labeled alanine incorporation into myofibrillar muscle protein synthesis can be measured.
3 days
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.
10 hours
Secondary Outcomes (8)
D5-phenylalanine incorporation
3 days
Muscle protein synthesis
10 hours
Protein synthesis
10 hours
Protein breakdown
10 hours
Phenylalanine oxidation
10 hours
- +3 more secondary outcomes
Study Arms (2)
MINCED-SKEWED
PLACEBO COMPARATORMinced meat administered with a skewed protein distribution pattern
MINCED-EVEN
EXPERIMENTALMinced meat administered with an even protein distribution pattern
Interventions
Study effect of an even or skewed distribution pattern of dietary protein
Eligibility Criteria
You may qualify if:
- Men and women
- Between 65-80 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Sports Medicine Copenhagen
Copenhagen, DK-2400, Denmark
Related Publications (1)
Agergaard J, Justesen TEH, Jespersen SE, Tagmose Thomsen T, Holm L, van Hall G. Even or skewed dietary protein distribution is reflected in the whole-body protein net-balance in healthy older adults: A randomized controlled trial. Clin Nutr. 2023 Jun;42(6):899-908. doi: 10.1016/j.clnu.2023.04.004. Epub 2023 Apr 8.
PMID: 37086618DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Postdoc
Study Record Dates
First Submitted
January 18, 2019
First Posted
March 12, 2019
Study Start
April 9, 2019
Primary Completion
June 30, 2020
Study Completion
February 28, 2022
Last Updated
November 21, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share