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Completed

NCT Number: NCT02053441

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

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.

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Key information

Age range

60 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Nottingham (Derby campus)

Derby, Derbyshire, DE22 3NE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Blood flow (bulk and nutritive) and intramuscular cell signalling

    Time frame: 7 Hours

    • Leg blood flow via Common femoral bulk flow (Doppler ultrasound)
    • Microvascular blood flow via contrast enhanced ultrasound
    • Mammalian Target of Rapamycin-1 (mTORC1) and Protein Kinase B (PKB or AKT) phosphorylation via western immunoblotting

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2014
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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