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Clinical Trials in Italy / NCT06309563
Recruiting Not applicable

Metabolic Effects of a Diet Replaced With Essential Amino Acids

NCT06309563 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Auxologico Italiano
Phase
Not applicable
Started
2023-08-30
Last updated
2026-03-31

Condition(s) studied

Obesity MorbidWeight Loss

Investigational drug(s) / intervention(s)

Aminoacid supplementationPlacebo

Aminoacid supplementation: Low-calorie and low-protein diet + with 4 sachets of EEA-AC supplement per day for 2 weeks

Placebo: Low-calorie and low-protein diet + placebo for 2 weeks

Study summary

The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.

1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.

Eligibility

Sex
ALL
Min age
45 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: \- Obesity (BMI \>35kg/m2) Exclusion Criteria: * Type 2 diabetes mellitus * Renal failure * Heart failure (New York Heart Association NYHA, class IV) * Liver cirrhosis * Neoplasms * Muscular or non-autonomic pathologies * Neurological-neurodegenerative pathologies * Cognitive decline * Non-menopausal women. * Patients who have undergone bariatric surgery in the previous 12 months * Patients on pharmacological treatment for weight loss in the last three weeks * Patients using vitamin and amino acid supplements in the last three weeks * Patients on hormone therapy (e.g. L-thyroxine, testosterone).

Primary outcome measure(s)

  • Muscle mass — At baseline and at 2 weeks after start of intervention
    Change in muscle mass during weight loss assessed through changes in body composition

Trial sites (1)

FacilityCityRegionStatus
Istituto Auxologico Italiano, Site Piancavallo Oggebbio Verbania Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06309563 on ClinicalTrials.gov ↗ ← All trials in Italy