Sarcopenia
Conditions
Brief summary
This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids and vitamin D concurrent with regular, controlled physical activity would increase muscle mass, strength, physical functional, quality of life, and decrease the risk of malnutrition and inflammation in sarcopenic elderly.
Detailed description
This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation (32 g) with whey protein, essential amino acids and vitamin D concurrent with regular, controlled physical activity would increase muscle mass (assessed by DXA), strength (assessed by handgrip dynamometer), physical functional (assessed by ADL), quality of life (assessed by SF-36), and decrease the risk of malnutrition (assessed by MNA and IGF-I) and inflammation (assessed by C-reactive protein) in sarcopenic elderly.
Interventions
DIETARY_SUPPLEMENTdietary supplement
oral essential amino acid (EAA), whey protein and vitamin D mixture
DIETARY_SUPPLEMENTplacebo
placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product
Sponsors
University of Pavia
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Eligible patients were aged 65 years or older with appendicular skeletal muscle mass/height2 2SD below mean of young adults (Baumgartner R, 1998), so with relative muscle mass \< 7.26 kg/m2 for men and \< 5.5 kg/m2 for women. * Patients were not affected by acute illness, severe liver, heart or kidney dysfunction, and had a body weight which had been stable for 6 months
Exclusion criteria
* Subjects with altered glycometabolic control, disthyroidism and other endocrinopathies and cancers, as well as patients treated with steroids and heparin, or with total walking incapacity were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle mass assessed by dual x-ray absorptiometry | 3 months | muscle mass assessed by dual x-ray absorptiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| muscle strength assessed by handgrip dynamometer | 3 months | muscle strength assessed by handgrip dynamometer |
| quality of life assessed by SF-36 | 3 months | quality of life assessed by SF-36 |
| inflammation assessed by C-reactive protein | 3 months | inflammation assessed by C-reactive protein |
| GH-IGF-I axsis by Insulin like growth factor -I (IGF-I) | 3 months | Insulin like growth factor -I (IGF-I) |
| functionality assessed by activity daily living | 3 months | assessed by activity daily living |
| fat mass distribution assessed by DXA | 3 months | body composition assessed by DXA |
| malnutrition assessed by Mini Nutritional Assessment | 3 months | malnutrition assessed by Mini Nutritional Assessment |
Countries
Italy
Outcome results
None listed