Nutritional Supplementation in Sarcopenic Obesity (SARCO)

Istituto Auxologico Italiano

Status: Completed

Conditions: Sarcopenic Obesity

Treatments: Dietary Supplement: Diet + protein; Dietary Supplement: Diet + EAA and TCA; Dietary Supplement: Diet + EAA; Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05143398

2018_06_28_05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Diet Arm

Active Comparator group

Description:

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

Treatment:

Other: Diet

Protein Arm

Active Comparator group

Description:

low-calorie diet normoproteic + an integration of 8.72 g of protein in the form of a nutritional supplement (18-20% protein)

Treatment:

Dietary Supplement: Diet + protein

EAA Arm

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: Diet + EAA

EAA + TCA

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Diet + EAA and TCA