NCT06309563Recruiting
Metabolic Effects of a Diet Replaced With Essential Amino Acids
Study on the Metabolic Effects of a Diet Replaced With Essential Amino Acids and Carboxylic Acids (EAA-AC) in Patients With Severe Obesity
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 7 Mar 2024
- Start date
- 30 Aug 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Istituto Auxologico Italiano
- Diseases
- Obesity
- NCT number
- NCT06309563
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 30 Aug 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone bariatric surgery in the previous 12 months
- Patients on hormone therapy (e.g. L-thyroxine, testosterone).
Other illness
- Type 2 diabetes mellitus
- Renal failure
- Heart failure (New York Heart Association NYHA, class IV)
Other
- Liver cirrhosis
- Neoplasms
- Muscular or non-autonomic pathologies
- Neurological-neurodegenerative pathologies
- Cognitive decline
- Non-menopausal women.
- Patients on pharmacological treatment for weight loss in the last three weeks
- Patients using vitamin and amino acid supplements in the last three weeks
Who the study is looking for
- \- Obesity (BMI \>35kg/m2)
Age in the registry: 45 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Auxologico Italiano, Site Piancavallo Coordinator of this site? Confirm its status | Oggebbio | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.