Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dietary supplement

oral essential amino acid (EAA), whey protein and vitamin D mixture (32 g)

Group Type ACTIVE_COMPARATOR

dietary supplement

Intervention Type 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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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dietary supplement

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

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No