RecruitingNot ApplicableNCT06309563

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


Sponsor

Istituto Auxologico Italiano

Enrollment

60 participants

Start Date

Aug 30, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether a low-calorie, low-protein diet supplemented with essential amino acids and tricarboxylic acids (EAA-AC) can help preserve muscle mass while promoting weight loss in adults with severe obesity (BMI above 35) during a 2-week inpatient rehabilitation program. Losing muscle along with fat is a common problem during weight loss programs, and the amino acid formula may help prevent this. Eligible participants are adults aged 45–65 with obesity who do not have type 2 diabetes, kidney failure, liver cirrhosis, cancer, or other major conditions, and who have not had bariatric surgery or weight loss medication recently. Participation involves following the assigned diet for 2 weeks in the clinic, with body composition and functional tests (including grip strength and walking tests) before and after, plus a follow-up appointment one month later. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTAminoacid supplementation

Low-calorie and low-protein diet + with 4 sachets of EEA-AC supplement per day for 2 weeks

DIETARY_SUPPLEMENTPlacebo

Low-calorie and low-protein diet + placebo for 2 weeks


Locations(1)

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, Italy

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NCT06309563


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