Nutritional Supplementation in Sarcopenic Obesity

NCT05143398 | Completed DMC

• 1 other identifier: 2018_06_28_05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenic Obesity

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (4)

Diet Arm

ACTIVE COMPARATOR

low-calorie diet normoproteic with an energy deficit of 15% compared to what emerged from the calorimetric value (basal REE)

Other: Diet

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)

Dietary Supplement: Diet + 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).

Dietary Supplement: Diet + EAA

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)

Dietary Supplement: Diet + EAA and TCA

Interventions

Diet + protein DIETARY_SUPPLEMENT

Comparison of the efficacy

Protein Arm

Diet + EAA DIETARY_SUPPLEMENT

Comparison of the efficacy

EAA Arm

Diet + EAA and TCA DIETARY_SUPPLEMENT

Comparison of the efficacy

EAA + TCA

Diet OTHER

Comparison of the efficacy

Diet Arm

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with obesity (BMI\> 35kg / m2)
• sarcopenia (criteria described in Coltorti A et al).

You may not qualify if:

• renal insufficiency
• diabetes
• muscular pathologies
• neurological-neurodegenerative pathologies
• cognitive decline

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Amelia Brunani

Verbania, VB, 28921, Italy

Location

Related Publications (10)

• 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.

  PMID: 31505890 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.

  PMID: 17702878 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.

  PMID: 18580399 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.

  PMID: 28539168 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.

  PMID: 21636183 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.

  PMID: 20889128 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.

  PMID: 18514630 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.

  PMID: 21566257 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.

  PMID: 1944015 BACKGROUND

• 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.

  PMID: 37445292 DERIVED

MeSH Terms

Interventions

Diet; Proteins; Excitatory Amino Acids

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Amino Acids, Peptides, and Proteins; Amino Acids

Study Officials

• Amelia Brunani, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Unit

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 3, 2021
• Study Start: September 1, 2018
• Primary Completion: October 15, 2020
• Study Completion: March 10, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)