Effects of a diet with essential amino acids on weight loss in obese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a low-calorie, low-protein diet supplemented with essential amino acids (EAA) in patients with high-grade obesity. Participants aged 45 to 65 will be randomly assigned to either an EAA supplement group or a placebo group while following the diet. The primary outcomes measured after two weeks will include weight loss and maintenance of muscle mass. The study aims to determine if the EAA supplementation enhances the weight loss effects compared to a standard diet.

Why it matters

Who can join: the full rules

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's running

• Istituto Auxologico Italiano, Site Piancavallo
  Oggebbio, Verbania, Italy Recruiting

Study contacts

• Study coordinator: Amelia Brunani, MD
• Email: brunani@auxologico.it
• Phone: 390323514232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.