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Modulation of Muscle Protein Synthesis With Diet and Exercise in Old Aged Women

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ClinicalTrials.gov Identifier: NCT02053441
Recruitment Status : Unknown
Verified December 2015 by University of Nottingham.
Recruitment status was:  Recruiting
First Posted : February 3, 2014
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
In this study will measure differences in how muscle responds to both exercise and protein supplements in healthy women aged 60-69. We are studying two different protein supplements- a standard Whey Protein and a Leucine enriched supplement. Each patient would receive either one of these.

Condition or disease
Sarcopenia

Detailed Description:
One of the factors that plays an important role in the loss of functional performance and, as such, the capacity to maintain a healthy, active lifestyle is the progressive loss of skeletal muscle mass with ageing (i.e., sarcopenia). Indeed, sarcopenia is a more robust predictor of functional status and mortality in the elderly than chronological age or indeed, any other co-morbidity. Sarcopenia is an incipient process whereby lean muscle mass contributing up to ~50% of total body weight in young adults declines to ~25% when reaching the age of 75-80 y. Adequate nutritional intake, and in particular dietary protein, is important for offsetting age-related declines in muscle mass. The aim of this project is to seek the most effective nutrition with which to counteract sarcopenia, specifically in women.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Efficacy of Leucine Enriched-EAA Supplements vs. Whey Protein in the Modulation of Muscle Protein Synthesis, Albumin Synthesis and Leg/ Muscle Blood Flow in Older Women
Study Start Date : January 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : September 2016



Primary Outcome Measures :
  1. Muscle protein synthesis and muscle protein breakdown [ Time Frame: 7 Hours ]
    Markers of muscle protein synthesis and breakdown are determined from muscle biopsy samples in form of myofibrillar Fractional Synthetic Rate (FSR) assessed by gas-chromatography-combustion-mass spectrometry, using incorporation of a stable isotope tracer (13-C-6 Phe)


Secondary Outcome Measures :
  1. Blood flow (bulk and nutritive) and intramuscular cell signalling [ Time Frame: 7 Hours ]
    1. Leg blood flow via Common femoral bulk flow (Doppler ultrasound)
    2. Microvascular blood flow via contrast enhanced ultrasound
    3. Mammalian Target of Rapamycin-1 (mTORC1) and Protein Kinase B (PKB or AKT) phosphorylation via western immunoblotting


Biospecimen Retention:   Samples With DNA
Blood samples for Glucose and RNA analysis Muscle biopsies for protein synthesis


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy females aged 60-70
Criteria

Inclusion Criteria:

  • Healthy post-menopausal females aged 60-70

Exclusion Criteria:

  • • Obvious muscle wasting.

    • A body mass index (BMI) < 18 or > 40 kg•m2.
    • Active cardiovascular disease: uncontrolled high blood pressure, angina, heart failure (class III/IV), abnormal heart rhythm, right to left cardiac shunt or recent cardiac event.
    • Taking statin-based medication above 60mg•day-1.
    • Individuals taking beta-adrenergic blocking agents or Non-steroidal anti-inflammatory agents (NSAIDS)
    • Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial).
    • Respiratory disease including pulmonary hypertension, chronic obstructive pulmonary disease (COPD), asthma or a forced expiratory volume (FEV1) less than 1.5 litres.
    • Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes.
    • Active inflammatory bowel disease, renal disease, or malignancy.
    • Recent steroid treatment (within 6 months), or hormone replacement therapy.
    • Clotting dysfunction e.g. Deep vein thrombosis, pulmonary embolus, warfarin therapy and/ or haemophilia.
    • Musculoskeletal or neurological disorders.
    • Any leg amputated
    • Family history of early (<55y) death from cardiovascular disease.
    • Known sensitivity to SONOVUE (US contrast).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053441


Contacts
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Contact: Philip Atherton, PhD +44 (0) 01332 724725 philip.atherton@nottingham.ac.uk
Contact: Syed Bukhari, MBBS 0044 7809239232 mzxsb@nottingham.ac.uk

Locations
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United Kingdom
University of Nottingham (Derby campus) Recruiting
Derby, Derbyshire, United Kingdom, DE22 3NE
Contact: Philip Atherton, PhD    0044 (0) 01332 724725    philip.atherton@nottingham.ac.uk   
Contact: Syed SI Bukhari, MBBS    00447809239232    mzxsb@nottingham.ac.uk   
Principal Investigator: Kenneth Smith, PhD         
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Kenneth Smith, PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02053441     History of Changes
Other Study ID Numbers: C14082012
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by University of Nottingham:
Muscle Protein Synthesis
Muscle Protein Breakdown

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms