Effects of a diet with essential amino acids on weight loss in obese patients
Study on the Metabolic Effects of a Diet Replaced With Essential Amino Acids and Carboxylic Acids (EAA-AC) in Patients With Severe Obesity
This study is testing if adding essential amino acids to a low-calorie diet can help obese people lose weight while keeping their muscle mass.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Oggebbio, Verbania) |
| Trial ID | NCT06309563 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 to 65 with a BMI greater than 35 kg/m² suffering from high-grade obesity.
Not a fit: Patients with type 2 diabetes, renal failure, heart failure, liver cirrhosis, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve weight loss outcomes and muscle preservation in obese patients.
How similar studies have performed: Previous studies have shown positive effects of amino acid supplementation in weight loss, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Oggebbio, Verbania
- Istituto Auxologico Italiano, Site Piancavallo — Oggebbio, Verbania, Italy (Recruiting)
Study contacts
- Study coordinator: Amelia Brunani, MD
- Email: brunani@auxologico.it
- Phone: 390323514232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.