Metabolic Effects of a Diet Replaced With Essential Amino Acids
Recruiting · NCT06309563 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Auxologico Italiano
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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).
Where it is running
1 location listed.
- Istituto Auxologico Italiano, Site Piancavallo - Oggebbio, Verbania, Italy