Sarcopenic Obesity
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTDiet + protein
Comparison of the efficacy
DIETARY_SUPPLEMENTDiet + EAA
Comparison of the efficacy
DIETARY_SUPPLEMENTDiet + EAA and TCA
Comparison of the efficacy
OTHERDiet
Comparison of the efficacy
Sponsors
Istituto Auxologico Italiano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
50 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients with obesity (BMI\> 35kg / m2) * sarcopenia (criteria described in Coltorti A et al).
Exclusion criteria
* renal insufficiency * diabetes * muscular pathologies * neurological-neurodegenerative pathologies * cognitive decline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Body weight | basal and at 4 weeks | weight in kilograms |
| Change of Height | basal and at 4 weeks | height in meters |
| Change of BMI | basal and at 4 weeks | weight and height will be combined to report BMI in kg/m\^2 |
| Change of Waist | basal and at 4 weeks | waist circumference in centimeters |
| Change of FM | basal and at 4 weeks | Fat Mass (FM) in % of body weight in kilograms |
| Change of FFM | basal and at 4 weeks | Free Fat Mass (FFM) in % of body weight in kilograms |
| Change of MM | basal and at 4 weeks | Muscle Mass (MM) in % of body weight in kilograms |
| Change of Muscle strenght | basal and at 4 weeks | muscle streght at the hand (right and left) in kg |
| Change of Walking | basal and at 4 weeks | 6 minute walk test (6MWT), meters walking in 6 minutes |
| Change of TUG | basal and at 4 weeks | time, in second, to up from the chair, walks 3 meters, turns around, walks back to the chair and sits down |
| Change of Metabolic profile | basal and at 4 weeks | glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl |
| Change of Insulin secretion | basal and at 4 weeks | insulin pasma levels in mU/l |
| Change of Homa index | basal and at 4 weeks | glycaemia and insulin will be combined to report Homa index in mmol/l/mU/l |
| Change of Muscle function | basal and at 4 weeks | irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml |
| Change of Muscle wasting | basal and at 4 weeks | C-terminal agrin fragment (CAF) in pg/ml |
Countries
Italy
Outcome results
None listed