Distribution of Nutrient Derived Amino Acids

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03870425
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.7
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Mass; Protein Intake; Diet Modification; Protein Synthesis; Protein Breakdown; Sarcopenia	Other: Distribution pattern of dietary proteins (minced meat)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlledRandomized controlled
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Distribution of Nutrient Derived Amino Acids and Anabolic Effect in Healthy Elderly Individuals
• Actual Study Start Date: Apr 9, 2019
• Anticipated Primary Completion Date: Jun 30, 2020
• Anticipated Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: MINCED-SKEWED Minced meat administered with a skewed protein distribution pattern	Other: Distribution pattern of dietary proteins (minced meat); Study effect of an even or skewed distribution pattern of dietary protein
Experimental: MINCED-EVEN Minced meat administered with an even protein distribution pattern	Other: Distribution pattern of dietary proteins (minced meat); Study effect of an even or skewed distribution pattern of dietary protein

Outcome Measures

Primary Outcome Measures

1. Muscle protein synthesis [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 [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 Outcome Measures

1. D5-phenylalanine incorporation [3 days]

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

2. Muscle protein synthesis [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 [10 hours]

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

4. Protein breakdown [10 hours]

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

5. Phenylalanine oxidation [10 hours]

   Phenylalanine oxidation measured during acute study

6. D5-phenylalanine appearance [12 hours]

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

7. Signaling pathways in skeletal muscle [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 [12 hours]

   Plasma insulin concentration during acute study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Sports Medicine Copenhagen	Copenhagen		Denmark	DK-2400

Sponsors and Collaborators

• Bispebjerg Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jakob Agergaard, PhD, Postdoc, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT03870425
• Other Study ID Numbers: BBH 140
• First Posted: Mar 12, 2019
• Last Update Posted: Apr 10, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jakob Agergaard, PhD, Postdoc, Bispebjerg Hospital: Dietary protein; Sarcopenia; Protein turnover; Muscle protein
• Additional relevant MeSH terms: Sarcopenia

Study Results

No Results Posted as of Apr 10, 2019