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Completed

NCT Number: NCT02402608

Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Supplement

Dietary Supplement

oral essential amino acid (EAA), whey protein and vitamin D mixture

Placebo

Dietary Supplement

placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product

Primary outcomes

  1. muscle mass assessed by dual x-ray absorptiometry

    Time frame: 3 months

    muscle mass assessed by dual x-ray absorptiometry

Secondary outcomes

  1. muscle strength assessed by handgrip dynamometer

    Time frame: 3 months

    muscle strength assessed by handgrip dynamometer

  2. quality of life assessed by SF-36

    Time frame: 3 months

    quality of life assessed by SF-36

  3. inflammation assessed by C-reactive protein

    Time frame: 3 months

    inflammation assessed by C-reactive protein

  4. malnutrition assessed by Mini Nutritional Assessment

    Time frame: 3 months

    malnutrition assessed by Mini Nutritional Assessment

  5. functionality assessed by activity daily living

    Time frame: 3 months

    assessed by activity daily living

  6. fat mass distribution assessed by DXA

    Time frame: 3 months

    body composition assessed by DXA

  7. GH-IGF-I axsis by Insulin like growth factor -I (IGF-I)

    Time frame: 3 months

    Insulin like growth factor -I (IGF-I)

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Collaborators

  • University of Pavia

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2015
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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