Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

Study Overview
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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.

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.

Official Title
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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

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: dietary supplement
* Dietary Supplement: placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dietary supplement<br>oral essential amino acid (EAA), whey protein and vitamin D mixture (32 g) | Dietary Supplement: dietary supplement<br>* oral essential amino acid (EAA), whey protein and vitamin D mixture<br>|
| Placebo Comparator: placebo<br>placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product | Dietary Supplement: placebo<br>* placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass assessed by dual x-ray absorptiometry | muscle mass assessed by dual x-ray absorptiometry | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength assessed by handgrip dynamometer | muscle strength assessed by handgrip dynamometer | 3 months | 
| quality of life assessed by SF-36 | quality of life assessed by SF-36 | 3 months | 
| inflammation assessed by C-reactive protein | inflammation assessed by C-reactive protein | 3 months | 
| malnutrition assessed by Mini Nutritional Assessment | malnutrition assessed by Mini Nutritional Assessment | 3 months | 
| functionality assessed by activity daily living | assessed by activity daily living | 3 months | 
| fat mass distribution assessed by DXA | body composition assessed by DXA | 3 months | 
| GH-IGF-I axsis by Insulin like growth factor -I (IGF-I) | Insulin like growth factor -I (IGF-I) | 3 months |