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

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053441
• Other study ID #: C14082012
• Status: Completed
• Start date: January 2013
• Est. completion date: September 2018

Study information

• Verified date: March 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Sarcopenia

Locations

Country	Name	City	State
United Kingdom	University of Nottingham (Derby campus)	Derby	Derbyshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Bukhari SS, Phillips BE, Wilkinson DJ, Limb MC, Rankin D, Mitchell WK, Kobayashi H, Greenhaff PL, Smith K, Atherton PJ. Intake of low-dose leucine-rich essential amino acids stimulates muscle anabolism equivalently to bolus whey protein in older women at — View Citation

Wilkinson DJ, Bukhari SSI, Phillips BE, Limb MC, Cegielski J, Brook MS, Rankin D, Mitchell WK, Kobayashi H, Williams JP, Lund J, Greenhaff PL, Smith K, Atherton PJ. Effects of leucine-enriched essential amino acid and whey protein bolus dosing upon skelet — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle protein synthesis and muscle protein breakdown	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)	7 Hours
Secondary	Blood flow (bulk and nutritive) and intramuscular cell signalling	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	7 Hours