Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

Sarcopenia Clinical Trial

Official title:

Whey Protein, Amino Acids and Vitamin D Supplementation With Physical Activity Increases Muscle Mass and Strength, Functionality and Quality of Life and Decreases Inflammation in Sarcopenic Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402608
• Other study ID #: ASP-1
• Status: Completed
• Phase: N/A
• First received: March 22, 2015
• Last updated: March 25, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthItaly: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• dietary supplement
oral essential amino acid (EAA), whey protein and vitamin D mixture
• placebo
placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product

Locations

Country	Name	City	State
Italy	geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia	University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Bjorkman MP, Suominen MH, Pitkälä KH, Finne-Soveri HU, Tilvis RS. Porvoo sarcopenia and nutrition trial: effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial. Trials. 2013 Nov 14;14:387. doi: 10.1186/1745-6215-14-387. — View Citation

Rondanelli M, Faliva M, Monteferrario F, Peroni G, Repaci E, Allieri F, Perna S. Novel insights on nutrient management of sarcopenia in elderly. Biomed Res Int. 2015;2015:524948. doi: 10.1155/2015/524948. Epub 2015 Jan 29. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle mass assessed by dual x-ray absorptiometry	muscle mass assessed by dual x-ray absorptiometry	3 months	Yes
Secondary	muscle strength assessed by handgrip dynamometer	muscle strength assessed by handgrip dynamometer	3 months	Yes
Secondary	quality of life assessed by SF-36	quality of life assessed by SF-36	3 months	Yes
Secondary	inflammation assessed by C-reactive protein	inflammation assessed by C-reactive protein	3 months	Yes
Secondary	malnutrition assessed by Mini Nutritional Assessment	malnutrition assessed by Mini Nutritional Assessment	3 months	Yes
Secondary	functionality assessed by activity daily living	assessed by activity daily living	3 months	Yes
Secondary	fat mass distribution assessed by DXA	body composition assessed by DXA	3 months	Yes
Secondary	GH-IGF-I axsis by Insulin like growth factor -I (IGF-I)	Insulin like growth factor -I (IGF-I)	3 months	Yes