Modulation of Muscle Protein Metabolism by Essential Amino Acids

Old Age Clinical Trial

— Aj1B  

Official title:

Modulation of Muscle Protein Metabolism by Essential Amino Acids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01890369
• Other study ID #: B13122012 GEM BMS
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2013
• Last updated: January 16, 2014
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2014
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Muscles can stay very constant in size for much of adult life yet dramatic wasting is seen in advanced age and ill health. A better understanding of how muscles regulate their size will help design treatments to slow wasting in disease and to promote active aging. We plan to study a group of older men, ~70yrs, the age at which muscle bulk starts to decrease, to observe how the muscles respond to feeding. We will provide a drink that contains the digested products of proteins from which muscles are built. Taking blood samples and some tiny biopsies of muscle (done under local anaesthesia) will allow us to measure muscle turnover and we will be able to measure for how long after a meal muscles actively take in nutrients before becoming "full". We will also measure how long the muscle remains "full" before it returns to a state where it can again be stimulated to take in nutrients. We will also explore if leucine, one of the component parts of protein (especially in meat and dairy products) and a food widely used supplement, can promote the early re-stimulation of muscle by eating.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male

• 65-75yrs

• BMI 18-28

Exclusion Criteria:

• Type 2 Diabetes mellitus

• Neurological Disease

• Significant cardiac, hepatic or renal disease

• Active malignancy

• Medication inc. Corticosteroids, NSAID use, Beta adrenoblockers.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Old Age

Intervention

Dietary Supplement:
• 15g Mixed Essential Amino Acids
Dissolved in 250ml water.
• 3g Leucine
Dissolved in 250ml water.
• 15g Mixed Essential Amino Acid REFEED
Dissolved in 250ml water.

Locations

Country	Name	City	State
United Kingdom	School of Graduate Entry Medicine	Derby

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Ajinomoto Co., Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myofibrillar Fractional Synthetic Rate	Assessed by gas-chromatography-combustion-mass spectrometry, using incorporation of a stable isotope tracer (13-C-6 Phe)	6-10hrs	No
Secondary	Leg blood flow	Common femoral bulk flow (Doppler USS)	6-10hrs	No
Secondary	mTORC1 and AKT phosphorylation	Western Immunoblotting	6-10hrs	No
Secondary	Muscle Protein Breakdown	By Arteriovenous limb balance	6-10hrs	No