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Recruiting NCT06309563

Metabolic Effects of a Diet Replaced With Essential Amino Acids

No phase Interventional Obesity Morbid Weight Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aminoacid supplementation, Placebo.
Who it may be relevant to
Registry conditions: Obesity Morbid, Weight Loss. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study on the Metabolic Effects of a Diet Replaced With Essential Amino Acids and Carboxylic Acids (EAA-AC) in Patients With Severe Obesity

Overview

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.

Interventions

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

Primary outcome measures

  • Muscle mass [Time frame: At baseline and at 2 weeks after start of intervention]
Secondary outcome measures (1)
  • 6 minute walking test (6MWT) [Time frame: At baseline and at 2 weeks after start of intervention]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Istituto Auxologico Italiano, Site Piancavallo — Oggebbio

Publications

  • Nisoli E, Falcone S, Tonello C, Cozzi V, Palomba L, Fiorani M, Pisconti A, Brunelli S, Cardile A, Francolini M, Cantoni O, Carruba MO, Moncada S, Clementi E. Mitochondrial biogenesis by NO yields functionally active mitochondria in mammals. Proc Natl Acad Sci U S A. 2004 Nov 23;101(47):16507-12. doi: 10.1073/pnas.0405432101. Epub 2004 Nov 15. PMID 15545607

Identifiers

NCT: NCT06309563 · 31J301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗