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

Completed

• Conditions: Sarcopenia

• Registration Number: NCT02053441
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle protein synthesis and muscle protein breakdown	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

Name	Time	Method
Blood flow (bulk and nutritive) and intramuscular cell signalling	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

Trial Locations

Locations (1)

University of Nottingham (Derby campus); 🇬🇧 Derby, Derbyshire, United Kingdom