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

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.

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

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.

Clinical Trials on Diet Modification

Clinical Trials on Distribution pattern of dietary proteins (minced meat)

3
Subscribe