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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Arm | Active Comparator | low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE) |
|
| Protein Arm | Active Comparator | low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein) |
|
| EAA Arm | Active Comparator | 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 | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet + protein | Dietary Supplement | Comparison of the efficacy |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amelia Brunani, MD | Istituto Auxologico Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amelia Brunani | Verbania | VB | 28921 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31505890 | Background | Hsu KJ, Liao CD, Tsai MW, Chen CN. Effects of Exercise and Nutritional Intervention on Body Composition, Metabolic Health, and Physical Performance in Adults with Sarcopenic Obesity: A Meta-Analysis. Nutrients. 2019 Sep 9;11(9):2163. doi: 10.3390/nu11092163. | |
| 17702878 | Background | Wang X, Miller GD, Messier SP, Nicklas BJ. Knee strength maintained despite loss of lean body mass during weight loss in older obese adults with knee osteoarthritis. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):866-71. doi: 10.1093/gerona/62.8.866. |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D011506 | Proteins |
| D018846 | Excitatory Amino Acids |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000602 | Amino Acids, Peptides, and Proteins |
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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.
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| Diet + EAA |
| Dietary Supplement |
Comparison of the efficacy |
|
| Diet + EAA and TCA | Dietary Supplement | Comparison of the efficacy |
|
| Diet | Other | Comparison of the efficacy |
|
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 |
| 18580399 | Background | Frimel TN, Sinacore DR, Villareal DT. Exercise attenuates the weight-loss-induced reduction in muscle mass in frail obese older adults. Med Sci Sports Exerc. 2008 Jul;40(7):1213-9. doi: 10.1249/MSS.0b013e31816a85ce. |
| 28539168 | Background | Malafarina V, Uriz-Otano F, Malafarina C, Martinez JA, Zulet MA. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial. Maturitas. 2017 Jul;101:42-50. doi: 10.1016/j.maturitas.2017.04.010. Epub 2017 Apr 22. |
| 21636183 | Background | Rondanelli M, Opizzi A, Antoniello N, Boschi F, Iadarola P, Pasini E, Aquilani R, Dioguardi FS. Effect of essential amino acid supplementation on quality of life, amino acid profile and strength in institutionalized elderly patients. Clin Nutr. 2011 Oct;30(5):571-7. doi: 10.1016/j.clnu.2011.04.005. Epub 2011 Jun 1. |
| 20889128 | Background | D'Antona G, Ragni M, Cardile A, Tedesco L, Dossena M, Bruttini F, Caliaro F, Corsetti G, Bottinelli R, Carruba MO, Valerio A, Nisoli E. Branched-chain amino acid supplementation promotes survival and supports cardiac and skeletal muscle mitochondrial biogenesis in middle-aged mice. Cell Metab. 2010 Oct 6;12(4):362-372. doi: 10.1016/j.cmet.2010.08.016. |
| 18514630 | Background | Solerte SB, Gazzaruso C, Bonacasa R, Rondanelli M, Zamboni M, Basso C, Locatelli E, Schifino N, Giustina A, Fioravanti M. Nutritional supplements with oral amino acid mixtures increases whole-body lean mass and insulin sensitivity in elderly subjects with sarcopenia. Am J Cardiol. 2008 Jun 2;101(11A):69E-77E. doi: 10.1016/j.amjcard.2008.03.004. |
| 21566257 | Background | Valerio A, D'Antona G, Nisoli E. Branched-chain amino acids, mitochondrial biogenesis, and healthspan: an evolutionary perspective. Aging (Albany NY). 2011 May;3(5):464-78. doi: 10.18632/aging.100322. |
| 1944015 | Background | Coltorti A, Scalfi L, Borrelli R, Contaldo F, Diaz E. [Validity of 5 bioelectric impedance equations for the estimation of lean body mass in women]. Minerva Endocrinol. 1991 Jan-Mar;16(1):37-41. Italian. |
| 37445292 | Derived | Brunani A, Cancello R, Gobbi M, Lucchetti E, Di Guglielmo G, Maestrini S, Cattaldo S, Pitera P, Ruocco C, Milesi A, Valerio A, Capodaglio P, Nisoli E. Comparison of Protein- or Amino Acid-Based Supplements in the Rehabilitation of Men with Severe Obesity: A Randomized Controlled Pilot Study. J Clin Med. 2023 Jun 25;12(13):4257. doi: 10.3390/jcm12134257. |
| D000596 | Amino Acids |