Metabolic Effects of Essential Amino Acids and Carboxylic Acids Supplementation in a Diet for Adults with Severe Obesity Aged 45 to 65

What this Trial Is About

This research aims to evaluate how effective a multidisciplinary rehabilitation program is for people with severe obesity, comparing those who receive a special formula of essential amino acids combined with tricarboxylic acids EAA-AC to those who do not. The study focuses on patients aged 45 to 65 with high-grade obesity. Researchers want to see if the amino acid supplement improves weight loss, muscle mass, mitochondrial function, and metabolic health. Participants will be randomly assigned to one of two groups. One group will follow a low-calorie, low-protein diet supplemented with four sachets per day of the EAA-AC formula for two weeks. The other group will follow the same diet but receive a placebo instead of the supplement. After the treatment period, patients will have a one-month outpatient follow-up to check muscle mass maintenance using body impedance analysis. During the study, researchers will assess muscle mass at the start and after two weeks, along with body composition and physical function tests like hand grip strength and walking tests 6MWT or TUG. They will also analyze mitochondrial function and circulating mitochondrial DNA levels. Blood tests will evaluate glucose control and lipid profiles. After discharge, participants return for a follow-up visit to evaluate muscle mass maintenance. The total participation period includes the initial two weeks of treatment plus the one-month follow-up.

Metabolic Effects of a Diet Replaced With Essential Amino Acids