Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance With Age; the Role of Amino Acids in Modulating Muscle Metabolism (Ajinomoto1A)

This study is currently recruiting participants.

Verified May 2013 by University of Nottingham

Sponsor:

Information provided by (Responsible Party):

University of Nottingham

ClinicalTrials.gov Identifier:

NCT01735539

First received: November 22, 2012

Last updated: May 9, 2013

Last verified: May 2013

History of Changes

Purpose

The investigators plan to measure changes in muscle protein metabolism in response to feeding, comparing between a single large essential amino acid (EAA) feed (the normal building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min intervals. The investigators will perform this study in healthy older (65-75y) and younger (18-28) men. The investigators will also explore how feeding affects muscle blood flow as this is important in the delivery of the nutrients we eat to the muscle where they are used.

The investigators plan to supplement the feed with arginine, a safe and widely found non-essential amino acid, to explore if this can improve muscle blood flow.

Condition	Intervention
Old Age (Focus; Not a Recognized Condition)	Dietary Supplement: 15g EAA bolus Dietary Supplement: 4 x 3.75g Mixed EAA Pulses Dietary Supplement: 15g EAA Bolus supplemented with 3g Arginine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance in Older People; The Role of Essential Amino Acids in Modulating Muscle Protein Metabolism; Bolus vs. Pulse Feeding Strategies and the Ability of Arginine to Rejuvenate Microvascular Responsiveness.

Resource links provided by NLM:

Drug Information available for: Arginine Arginine Hydrochloride Amino acids

U.S. FDA Resources

Further study details as provided by University of Nottingham:

Primary Outcome Measures:

Muscle Protein Synthesis (FSR, fractional synthetic rate, %/hr) [ Time Frame: Across 6hr study ] [ Designated as safety issue: No ]
We measure FSR when fasted and again 0-90, 90-180 and 180-240 post feed.

Secondary Outcome Measures:

Muscle Protein Breakdown (MPB) [ Time Frame: Across 6hr study ] [ Designated as safety issue: No ]
MBP is measured during fasting and 0-90, 90-180 and 180-240mins post feed.
Whole leg blood flow [ Time Frame: Across a 6hr study ] [ Designated as safety issue: No ]
We measure common femoral blood flow by doppler ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed.
Muscle Microvascular Blood flow [ Time Frame: Across a 6hr study ] [ Designated as safety issue: No ]
We measure muscle microvascular flow using contrast enhanced ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed.

Estimated Enrollment:	40
Study Start Date:	December 2011
Estimated Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Old Bolus 15g EAA bolus	Dietary Supplement: 15g EAA bolus Oral; in aqueous solution Other Name: Mixed Essential Amino Acids
Experimental: Old Arginine 15g EAA Bolus supplemented with 3g Arginine	Dietary Supplement: 15g EAA Bolus supplemented with 3g Arginine Oral; in aqueous solution
Experimental: Young Bolus 15g EAA bolus	Dietary Supplement: 15g EAA bolus Oral; in aqueous solution Other Name: Mixed Essential Amino Acids
Experimental: Young Pulse 4 x 3.75g Mixed EAA Pulses	Dietary Supplement: 4 x 3.75g Mixed EAA Pulses Oral; in aqueous solution
Experimental: Old Pulse 4 x 3.75g Mixed EAA Pulses	Dietary Supplement: 4 x 3.75g Mixed EAA Pulses Oral; in aqueous solution

Detailed Description:

We will provide a 15g mixed essential amino acid feed or 4 x 3.75g.

There is sexual dimorphism thus initially we will just recruit males. Powering calculations dictate n=8 in each group.

We will use well established stable isotope tracer techniques (with 13C6 Phenylalanine) to measure muscle protein synthesis and breakdown by Gas Chromatography - combustion - isotope ratio mass spectroscopy.

We will measure leg blood flow by phase shift Doppler and muscle microvascular flow by contrast enhanced ultrasound.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

age 65-75 or 18-28

Exclusion Criteria:

BMI >30
Diabetes
Beta blocker or steroid use
Established cerebrovascular, peripheral vascular or ischaemic heart disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735539

Locations

United Kingdom
University of Nottingham School of Graduate Entry Medicine and Health	Recruiting
Derby, United Kingdom, DE23 6PF
Contact: Kyle Mitchell, MB BChir mzxwm@nottingham.ac.uk
Principal Investigator: Philip J Atherton, PhD
Sub-Investigator: John P Williams, PhD MB BS

Sponsors and Collaborators

University of Nottingham

Investigators

Principal Investigator:

Philip J Atherton, PhD

University of Nottingham

More Information

No publications provided

Responsible Party:	University of Nottingham
ClinicalTrials.gov Identifier:	NCT01735539 History of Changes
Other Study ID Numbers:	UNottingham F/3/2009
Study First Received:	November 22, 2012
Last Updated:	May 9, 2013
Health Authority:	UK: University of Nottingham Medical School Research Ethics Committee UK: University of Nottingham HTA Compliance Group

Keywords provided by University of Nottingham:

old age
sarcopenia
essential amino acid
arginine

contrast enhanced ultrasound
muscle microcirculation
muscle protein synthesis

ClinicalTrials.gov processed this record on May 22, 2013

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