Nutritional Supplementation in Sarcopenic Obesity
Condition: Sarcopenic Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in
      the elderly subject that was named Sarcopenic Obesity (SO). The use of a diet that includes
      protein supplements and / or essential amino acids seems to improve this condition in the
      elderly; there are no similar studies in obese subjects, in particular during a low-calorie
      diet and physical activity program that can produce further loss of muscle mass. This study
      aims to verify whether the administration of these supplements (protein or amino acid) in the
      obese patient are effective in improving anthropometric and functional parameters and some
      serum markers of muscle metabolism. The results obtained could represent new therapeutic
      protocols in the treatment of obesity.
    

Detailed description: 
      Several studies have confirmed that adequate nutrition, especially protein intake, including
      at breakfast, or supplementation with amino acids, in association with adequate physical
      activity plays an important role in the treatment of SO.

      The supplementation of protein or amino acid preparations (in particular with the 9 essential
      amino acids including, the branched - leucine, isoleucine, valine), marketed in different
      formulations, has already allowed to document a significant therapeutic efficacy in the
      treatment of elderly sarcopenic subjects. In fact, the use of these preparations improves
      physical performance and muscle strength by inducing the synthesis of proteins involved in
      the biogenesis and functionality of mitochondria - that is, the cellular organelles
      responsible for the production of energy in the form of ATP - and of myofibrillar proteins
      (which constitute the large percentage of muscle mass), both in laboratory animals and in
      humans.
    

Intervention name(s): Diet + protein; Diet + EAA; Diet + EAA and TCA; Diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Comparison of the efficacy; Comparison of the efficacy; Comparison of the efficacy; Comparison of the efficacy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After 1 week of standard diet (1650kcal/day with 18% protein) without physical activity, patients will be randomized into one of the 4 arms described below (20 subjects per study arm): 1st arm: low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE); 2nd arm: low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein; 3rd diet: low-calorie diet normoproteic + amino acid supplement (2 sachet/daily; 1 sachet contains protein 0 gr, carbohydrates 6.69 gr , lipids 0 gr, i-leucine 1,2 gr, i-isoleucine 0,6 gr, i-valine 0,6 gr). 4th diet: low-calorie diet normoproteic + an amino acid supplement (2 stick/daily; 1 stick pack contains protein 0 gr, carbohydrates 1,046 gr, lipids 0.074 gr, i-leucine 1.2 gr, i-isoleucine 0.6 gr, i-valine 0.6 gr, citric acid, succinic acid and malic acid). All patients perform daily aerobic physical activity/5 days/week for 4 weeks.
Masking: None (Open Label)
Primary purpose: Treatment