Metabolic Effects of a Diet Replaced With Essential Amino Acids

Weight Loss Clinical Trial

— AMINOB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309563
• Other study ID #: 31J301
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Amelia Brunani, MD
• Phone: 390323514232
• Email: brunani[@]auxologico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Obesity Morbid
• Weight Loss

Intervention

Dietary Supplement:
• Aminoacid supplementation
Low-calorie and low-protein diet + with 4 sachets of EEA-AC supplement per day for 2 weeks
• Placebo
Low-calorie and low-protein diet + placebo for 2 weeks

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano, Site Piancavallo	Oggebbio	Verbania

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Nisoli E, Falcone S, Tonello C, Cozzi V, Palomba L, Fiorani M, Pisconti A, Brunelli S, Cardile A, Francolini M, Cantoni O, Carruba MO, Moncada S, Clementi E. Mitochondrial biogenesis by NO yields functionally active mitochondria in mammals. Proc Natl Acad Sci U S A. 2004 Nov 23;101(47):16507-12. doi: 10.1073/pnas.0405432101. Epub 2004 Nov 15. Erratum In: Proc Natl Acad Sci U S A. 2005 Apr 12;102(15):5635. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	Change in muscle mass during weight loss assessed through changes in body composition	At baseline and at 2 weeks after start of intervention
Secondary	6 minute walking test (6MWT)	Change in distance covered in 6 minutes of walking during weight loss	At baseline and at 2 weeks after start of intervention