- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03870425
Distribution of Nutrient Derived Amino Acids
November 18, 2022 updated by: Jakob Agergaard, Bispebjerg Hospital
Distribution of Nutrient Derived Amino Acids and Anabolic Effect in Healthy Elderly Individuals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, DK-2400
- Institute of Sports Medicine Copenhagen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: MINCED-SKEWED
Minced meat administered with a skewed protein distribution pattern
|
Study effect of an even or skewed distribution pattern of dietary protein
|
Experimental: MINCED-EVEN
Minced meat administered with an even protein distribution pattern
|
Study effect of an even or skewed distribution pattern of dietary protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 days
|
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.
|
10 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
D5-phenylalanine incorporation
Time Frame: 3 days
|
D5-phenylalanine incorporation into myofibrillar proteins.
Dietary meat proteins are intrinsically labeled with D5-phenylalanine
|
3 days
|
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.
|
10 hours
|
Protein synthesis
Time Frame: 10 hours
|
Whole body protein synthesis (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.
|
10 hours
|
Protein breakdown
Time Frame: 10 hours
|
Whole body protein breakdown (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.
|
10 hours
|
Phenylalanine oxidation
Time Frame: 10 hours
|
Phenylalanine oxidation measured during acute study
|
10 hours
|
D5-phenylalanine appearance
Time Frame: 12 hours
|
Plasma D5-phenylalanine enrichment after intake of D5-phenylalanine intrinsically labelled meat proteins
|
12 hours
|
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.
|
10 hours
|
Plasma insulin
Time Frame: 12 hours
|
Plasma insulin concentration during acute study
|
12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
January 18, 2019
First Submitted That Met QC Criteria
March 11, 2019
First Posted (Actual)
March 12, 2019
Study Record Updates
Last Update Posted (Actual)
November 21, 2022
Last Update Submitted That Met QC Criteria
November 18, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBH 140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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