Aj1B: Modulation of Muscle Protein Metabolism by Essential Amino Acids

Sponsor

University of Nottingham (Other)

Overall Status

Unknown status

CT.gov ID

NCT01890369

Collaborator

Ajinomoto Co., Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Old Age	Dietary Supplement: 15g Mixed Essential Amino Acids Dietary Supplement: 3g Leucine Dietary Supplement: 15g Mixed Essential Amino Acid REFEED	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Modulation of Muscle Protein Metabolism by Essential Amino Acids

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early leucine refeed 15g Mixed Essential Amino Acids. 90 min delay. 3g Leucine	Dietary Supplement: 15g Mixed Essential Amino Acids Dissolved in 250ml water. Dietary Supplement: 3g Leucine Dissolved in 250ml water.
Experimental: Early EAA refeed 15g Mixed Essential Amino Acids. 90 min delay. 15g Mixed Essential Amino Acid REFEED	Dietary Supplement: 15g Mixed Essential Amino Acids Dissolved in 250ml water. Dietary Supplement: 15g Mixed Essential Amino Acid REFEED Dissolved in 250ml water.
Experimental: Mid latency EAA refeed 15g Mixed Essential Amino Acids. 150 min delay. 15g Mixed Essential Amino Acid REFEED	Dietary Supplement: 15g Mixed Essential Amino Acids Dissolved in 250ml water. Dietary Supplement: 15g Mixed Essential Amino Acid REFEED Dissolved in 250ml water.
Experimental: Late latency EAA refeed 15g Mixed Essential Amino Acids. 210 min delay. 15g Mixed Essential Amino Acid REFEED	Dietary Supplement: 15g Mixed Essential Amino Acids Dissolved in 250ml water. Dietary Supplement: 15g Mixed Essential Amino Acid REFEED Dissolved in 250ml water.

Outcome Measures

Primary Outcome Measures

Myofibrillar Fractional Synthetic Rate [6-10hrs]
Assessed by gas-chromatography-combustion-mass spectrometry, using incorporation of a stable isotope tracer (13-C-6 Phe)

Secondary Outcome Measures

Leg blood flow [6-10hrs]
Common femoral bulk flow (Doppler USS)
mTORC1 and AKT phosphorylation [6-10hrs]
Western Immunoblotting
Muscle Protein Breakdown [6-10hrs]
By Arteriovenous limb balance

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Graduate Entry Medicine	Derby		United Kingdom	DE22 3DT

Sponsors and Collaborators

University of Nottingham
Ajinomoto Co., Inc.

Investigators

Principal Investigator: Philip J Atherton, PhD, University of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Nottingham

ClinicalTrials.gov Identifier:

NCT01890369

Other Study ID Numbers:

B13122012 GEM BMS

First Posted:

Jul 1, 2013

Last Update Posted:

Jan 17, 2014

Last Verified:

Jan 1, 2014

Keywords provided by University of Nottingham

Study Results

No Results Posted as of Jan 17, 2014