Modulation of Muscle Protein Metabolism by Essential Amino Acids

NCT ID: NCT01890369

Last Updated: 2014-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Old Age

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Early leucine refeed

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

Group Type EXPERIMENTAL

15g Mixed Essential Amino Acids

Intervention Type DIETARY_SUPPLEMENT

Dissolved in 250ml water.

3g Leucine

Intervention Type DIETARY_SUPPLEMENT

Dissolved in 250ml water.

Early EAA refeed

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

Group Type EXPERIMENTAL

15g Mixed Essential Amino Acids

Intervention Type DIETARY_SUPPLEMENT

Dissolved in 250ml water.

15g Mixed Essential Amino Acid REFEED

Intervention Type DIETARY_SUPPLEMENT

Dissolved in 250ml water.

Mid latency EAA refeed

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

Group Type EXPERIMENTAL

15g Mixed Essential Amino Acids

Intervention Type DIETARY_SUPPLEMENT

Dissolved in 250ml water.

15g Mixed Essential Amino Acid REFEED

Intervention Type DIETARY_SUPPLEMENT

Dissolved in 250ml water.

Late latency EAA refeed

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

Group Type EXPERIMENTAL

15g Mixed Essential Amino Acids

Intervention Type DIETARY_SUPPLEMENT

Dissolved in 250ml water.

15g Mixed Essential Amino Acid REFEED

Intervention Type DIETARY_SUPPLEMENT

Dissolved in 250ml water.

Interventions

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15g Mixed Essential Amino Acids

Dissolved in 250ml water.

Intervention Type DIETARY_SUPPLEMENT

3g Leucine

Dissolved in 250ml water.

Intervention Type DIETARY_SUPPLEMENT

15g Mixed Essential Amino Acid REFEED

Dissolved in 250ml water.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ajinomoto Co., Inc.

INDUSTRY

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip J Atherton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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School of Graduate Entry Medicine

Derby, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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William K Mitchell, MA,MB,BChir

Role: primary

(+44)1332 724681

Other Identifiers

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B13122012 GEM BMS

Identifier Type: -

Identifier Source: org_study_id

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