NCT06309563 Metabolic Effects of a Diet Replaced With Essential Amino Acids
| NCT ID | NCT06309563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Obesity Morbid |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-08-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06309563 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 65 Years, studying Obesity Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06309563 currently recruiting?
Yes, NCT06309563 is actively recruiting participants. Contact the research team at brunani@auxologico.it for enrollment information.
Where is the NCT06309563 trial being conducted?
This trial is being conducted at Oggebbio, Italy.
Who is sponsoring the NCT06309563 clinical trial?
NCT06309563 is sponsored by Istituto Auxologico Italiano. The trial plans to enroll 60 participants.
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