Nutritional Supplementation in Sarcopenic Obesity (SARCO)

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenic Obesity
• Intervention / Treatment: Other: Diet; Dietary supplement: Diet + protein; Dietary supplement: Diet + EAA; Dietary supplement: Diet + EAA and TCA

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • VB
    • Verbania, VB, Italy, 28921
      • Amelia Brunani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet Arm; low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE)	Other: Diet; Comparison of the efficacy
Active Comparator: Protein Arm; 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; Comparison of the efficacy
Active Comparator: EAA Arm; 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; Comparison of the efficacy
Active Comparator: EAA + 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)	Dietary supplement: Diet + EAA and TCA; Comparison of the efficacy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Amelia Brunani, MD, Istituto Auxologico Italiano

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2018_06_28_05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No