NCT05143398

Nutritional Supplementation in Sarcopenic Obesity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: Male
• Age: 50 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcopenic Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Diet + protein	Comparison of the efficacy
DIETARY_SUPPLEMENT	Diet + EAA	Comparison of the efficacy
DIETARY_SUPPLEMENT	Diet + EAA and TCA	Comparison of the efficacy
OTHER	Diet	Comparison of the efficacy

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-10-15
• Completion: 2021-03-10
• First posted: 2021-12-03
• Last updated: 2021-12-03

Locations

1 site across 1 country: Italy