Metabolic Effects of a Diet Replaced With Essential Amino Acids

Launched by ISTITUTO AUXOLOGICO ITALIANO · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a special diet supplemented with essential amino acids (EAA) can help people with severe obesity. The goal is to see if adding these amino acids to a low-calorie, low-protein diet can lead to better weight loss and help maintain muscle mass compared to a similar diet without the supplement. They will be recruiting men and women aged 45 to 65 who have a Body Mass Index (BMI) greater than 35, which indicates obesity. However, individuals with certain health issues, such as type 2 diabetes, heart or kidney failure, and those who have had recent weight loss surgeries, won't be eligible to participate.

Participants in the trial will be randomly assigned to either receive the amino acid supplement or a placebo (which looks like the supplement but has no active ingredients) while following the diet for two weeks. After this period, the researchers will check how well each group lost weight, maintained muscle mass, and improved their blood sugar and fat levels. One month after finishing the trial, participants will have a follow-up appointment to see if they continued to keep their muscle mass. This study will help understand if this new dietary approach can be beneficial for people struggling with obesity.

Gender

ALL

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).