NCT01890369

Brief Summary

The investigators plan to explore the ability of amino acids, the building blocks of proteins in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. The investigators will investigate how rapidly after one meal the human body is ready to make use of a second meal and look at the molecular mechanisms underlying this. The investigators will look at these phenomena in older men as this group is known to be subject to a gradual loss of muscle mass and strength.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

June 26, 2013

Last Update Submit

January 16, 2014

Conditions

Old Age

Keywords

Old AgeSarcopeniaAmino AcidMuscle

Outcome Measures

Primary Outcomes (1)

  • Myofibrillar Fractional Synthetic Rate

    Assessed by gas-chromatography-combustion-mass spectrometry, using incorporation of a stable isotope tracer (13-C-6 Phe)

    6-10hrs

Secondary Outcomes (3)

  • Leg blood flow

    6-10hrs

  • mTORC1 and AKT phosphorylation

    6-10hrs

  • Muscle Protein Breakdown

    6-10hrs

Study Arms (4)

Early leucine refeed

EXPERIMENTAL

15g Mixed Essential Amino Acids. 90 min delay. 3g Leucine

Dietary Supplement: 15g Mixed Essential Amino AcidsDietary Supplement: 3g Leucine

Early EAA refeed

EXPERIMENTAL

15g Mixed Essential Amino Acids. 90 min delay. 15g Mixed Essential Amino Acid REFEED

Dietary Supplement: 15g Mixed Essential Amino AcidsDietary Supplement: 15g Mixed Essential Amino Acid REFEED

Mid latency EAA refeed

EXPERIMENTAL

15g Mixed Essential Amino Acids. 150 min delay. 15g Mixed Essential Amino Acid REFEED

Dietary Supplement: 15g Mixed Essential Amino AcidsDietary Supplement: 15g Mixed Essential Amino Acid REFEED

Late latency EAA refeed

EXPERIMENTAL

15g Mixed Essential Amino Acids. 210 min delay. 15g Mixed Essential Amino Acid REFEED

Dietary Supplement: 15g Mixed Essential Amino AcidsDietary Supplement: 15g Mixed Essential Amino Acid REFEED

Interventions

15g Mixed Essential Amino AcidsDIETARY_SUPPLEMENT

Dissolved in 250ml water.

Early EAA refeedEarly leucine refeedLate latency EAA refeedMid latency EAA refeed
3g LeucineDIETARY_SUPPLEMENT

Dissolved in 250ml water.

Early leucine refeed
15g Mixed Essential Amino Acid REFEEDDIETARY_SUPPLEMENT

Dissolved in 250ml water.

Early EAA refeedLate latency EAA refeedMid latency EAA refeed

Eligibility Criteria

Age65 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male
  • yrs
  • BMI 18-28

You may not qualify if:

  • Type 2 Diabetes mellitus
  • Neurological Disease
  • Significant cardiac, hepatic or renal disease
  • Active malignancy
  • Medication inc. Corticosteroids, NSAID use, Beta adrenoblockers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Graduate Entry Medicine

Derby, DE22 3DT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Interventions

Leucine

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Philip J Atherton, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 1, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

GB(1)