Nutritional Supplementation in Sarcopenic Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of a Rehabilitation Program (Nutritional + Physical Activity) in Sarcopenic Obesity

Conditions
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Sarcopenic Obesity

Intervention / Treatment
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* Dietary Supplement: Diet + protein
* Dietary Supplement: Diet + EAA
* Dietary Supplement: Diet + EAA and TCA
* Other: Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet Arm<br>low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE) | Other: Diet<br>* Comparison of the efficacy<br>|
| Active Comparator: Protein Arm<br>low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein) | Dietary Supplement: Diet + protein<br>* Comparison of the efficacy<br>|
| Active Comparator: EAA Arm<br>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). | Dietary Supplement: Diet + EAA<br>* Comparison of the efficacy<br>|
| Active Comparator: EAA + TCA<br>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) | Dietary Supplement: Diet + EAA and TCA<br>* Comparison of the efficacy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Body weight | weight in kilograms | basal and at 4 weeks | 
| Change of Height | height in meters | basal and at 4 weeks | 
| Change of BMI | weight and height will be combined to report BMI in kg/m^2 | basal and at 4 weeks | 
| Change of Waist | waist circumference in centimeters | basal and at 4 weeks | 
| Change of FM | Fat Mass (FM) in % of body weight in kilograms | basal and at 4 weeks | 
| Change of FFM | Free Fat Mass (FFM) in % of body weight in kilograms | basal and at 4 weeks | 
| Change of MM | Muscle Mass (MM) in % of body weight in kilograms | basal and at 4 weeks | 
| Change of Muscle strenght | muscle streght at the hand (right and left) in kg | basal and at 4 weeks | 
| Change of Walking | 6 minute walk test (6MWT), meters walking in 6 minutes | basal and at 4 weeks | 
| Change of TUG | time, in second, to up from the chair, walks 3 meters, turns around, walks back to the chair and sits down | basal and at 4 weeks | 
| Change of Metabolic profile | glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl | basal and at 4 weeks | 
| Change of Insulin secretion | insulin pasma levels in mU/l | basal and at 4 weeks | 
| Change of Homa index | glycaemia and insulin will be combined to report Homa index in mmol/l/mU/l | basal and at 4 weeks | 
| Change of Muscle function | irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml | basal and at 4 weeks | 
| Change of Muscle wasting | C-terminal agrin fragment (CAF) in pg/ml | basal and at 4 weeks |