Nutritional Supplementation in Sarcopenic Obesity
- Conditions
- Sarcopenic Obesity
- Interventions
- Dietary Supplement: Diet + proteinOther: DietDietary Supplement: Diet + EAADietary Supplement: Diet + EAA and TCA
- Registration Number
- NCT05143398
- Lead Sponsor
- Istituto Auxologico Italiano
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
- patients with obesity (BMI> 35kg / m2)
- sarcopenia (criteria described in Coltorti A et al).
- renal insufficiency
- diabetes
- muscular pathologies
- neurological-neurodegenerative pathologies
- cognitive decline
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protein Arm Diet + protein low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein) Diet Arm Diet low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE) EAA Arm Diet + EAA 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). EAA + TCA Diet + EAA and TCA 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)
- Primary Outcome Measures
Name Time Method Change of Muscle function basal and at 4 weeks irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml
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 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 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 Height basal and at 4 weeks height in meters
Change of Muscle strenght basal and at 4 weeks muscle streght at the hand (right and left) in kg
Change of Insulin secretion basal and at 4 weeks insulin pasma levels in mU/l
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 Metabolic profile basal and at 4 weeks glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl
Change of Body weight basal and at 4 weeks weight in kilograms
Change of Walking basal and at 4 weeks 6 minute walk test (6MWT), meters walking in 6 minutes
Change of Muscle wasting basal and at 4 weeks C-terminal agrin fragment (CAF) in pg/ml
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Amelia Brunani
🇮🇹Verbania, VB, Italy