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NCT Number: NCT06309563

Metabolic Effects of a Diet Replaced With Essential Amino Acids

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28921, Italy

Location status: Recruiting

Location contact

Amelia Brunani, MD

CONTACT

[email protected]

390323514232

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Aminoacid supplementation

Dietary Supplement

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

Other names: EAA-AC, Controls

Placebo

Dietary Supplement

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

Primary outcomes

  1. Muscle mass

    Time frame: At baseline and at 2 weeks after start of intervention

    Change in muscle mass during weight loss assessed through changes in body composition

Secondary outcomes

  1. 6 minute walking test (6MWT)

    Time frame: At baseline and at 2 weeks after start of intervention

    Change in distance covered in 6 minutes of walking during weight loss

Study contacts

Contact information is provided by the study sponsor or research team.

Amelia Brunani, MD

CONTACT

[email protected]

390323514232

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Study on the Metabolic Effects of a Diet Replaced With Essential Amino Acids and Carboxylic Acids (EAA-AC) in Patients With Severe Obesity

Acronym: AMINOB

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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