Pilot:High-Protein Mediterranean Diet, Exercise and Sarcopenia V.1
Research type
Research Study
Full title
A high-PRotein Mediterranean diet and Resistance Exercise for cardiac rehabilitation: a pilot randomised controlled trial
IRAS ID
256927
Contact name
Fatima Perez de Heredia
Contact email
Sponsor organisation
Liverpool John Moores University
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The study aims to investigate whether a high-protein Mediterranean diet, alone or in combination with resistance exercise, can increase muscle mass in cardiac rehabilitation patients, and reduce the risk of future cardiac events.
Cardiovascular risk can be increased by different factors, such as obesity (an excess of body fat), or sarcopenia, which is a gradual loss of muscle mass that happens as we age. Sometimes both conditions can occur simultaneously, and the individual may appear to have a normal body weight, but have disproportionately low levels of muscle mass and high levels of body fat; this is known as sarcopenic obesity, and it is associated with greater risk of heart disease. Increasing the proportion of muscle mass to body fat in people with sarcopenic obesity may reduce the risk of future heart disease.
We will work with cardiac rehabilitation patients, recruited through the NHS. In the facilities of Liverpool John Moores University in Byrom Street campus, we will assess the presence of sarcopenic obesity, measuring body composition by dual energy X-ray absorptiometry (DXA), bio-impedance, and anthropometric measures (height, weight, waist circumference). DXA uses X-rays to create an image of the body which clearly shows bone, fat and lean muscle mass, while bio-impedance uses a low intensity electric current to estimate body fat.
Participants identified as having sarcopenic obesity will begin a lifestyle intervention in one of 4 different groups:
1-control: they will follow the usual cardiac rehabilitation dietary and exercise advice,
2-diet group: will follow a high-protein Mediterranean-style diet,
3-exercise group: will perform resistance exercise regularly,
4-diet and exercise group: will follow the experimental diet and the resistance exercise training.Before and after the intervention, we will measure muscle and body fat levels, muscle strength through simple function tests, and markers of cardiovascular health, including cholesterol sub-fractions, triglycerides, fasting glucose and insulin, and inflammatory proteins.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
19/NW/0762
Date of REC Opinion
24 Jan 2020
REC opinion
Further Information Favourable Opinion