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Completed

NCT Number: NCT05143398

Nutritional Supplementation 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.

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Key information

Conditions

Sarcopenic Obesity

Age range

50 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Amelia Brunani

Verbania, VB, 28921, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet + protein

Dietary Supplement

Comparison of the efficacy

Diet + EAA

Dietary Supplement

Comparison of the efficacy

Diet + EAA and TCA

Dietary Supplement

Comparison of the efficacy

Diet

Other

Comparison of the efficacy

Primary outcomes

  1. Change of Body weight

    Time frame: basal and at 4 weeks

    weight in kilograms

  2. Change of Height

    Time frame: basal and at 4 weeks

    height in meters

  3. Change of BMI

    Time frame: basal and at 4 weeks

    weight and height will be combined to report BMI in kg/m^2

  4. Change of Waist

    Time frame: basal and at 4 weeks

    waist circumference in centimeters

  5. Change of FM

    Time frame: basal and at 4 weeks

    Fat Mass (FM) in % of body weight in kilograms

  6. Change of FFM

    Time frame: basal and at 4 weeks

    Free Fat Mass (FFM) in % of body weight in kilograms

  7. Change of MM

    Time frame: basal and at 4 weeks

    Muscle Mass (MM) in % of body weight in kilograms

  8. Change of Muscle strenght

    Time frame: basal and at 4 weeks

    muscle streght at the hand (right and left) in kg

  9. Change of Walking

    Time frame: basal and at 4 weeks

    6 minute walk test (6MWT), meters walking in 6 minutes

  10. Change of TUG

    Time frame: basal and at 4 weeks

    time, in second, to up from the chair, walks 3 meters, turns around, walks back to the chair and sits down

  11. Change of Metabolic profile

    Time frame: basal and at 4 weeks

    glycaemia, total cholesterol, LDL cholesterol, triglycerides all in mg/dl

  12. Change of Insulin secretion

    Time frame: basal and at 4 weeks

    insulin pasma levels in mU/l

  13. Change of Homa index

    Time frame: basal and at 4 weeks

    glycaemia and insulin will be combined to report Homa index in mmol/l/mU/l

  14. Change of Muscle function

    Time frame: basal and at 4 weeks

    irisin and procollagen type III N-terminal peptide (P3NP) in ng/ml

  15. Change of Muscle wasting

    Time frame: basal and at 4 weeks

    C-terminal agrin fragment (CAF) in pg/ml

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: SARCO

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 3, 2021
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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