Clinical trial NCT06309563: Metabolic Effects of a Diet Replaced With Essential Amino Acids
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity Morbid
Weight Loss
Keywords: Muscle mass during weight loss
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Primary outcomes:
measure: Muscle mass
timeFrame: At baseline and at 2 weeks after start of intervention
Secondary outcomes:
measure: 6 minute walking test (6MWT)
timeFrame: At baseline and at 2 weeks after start of intervention
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano, Site Piancavallo
state: Verbania
Study officials:
References:
citation: 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.