Metabolic Effects of a Diet Replaced With Essential Amino Acids (AMINOB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss; Obesity Morbid
• Intervention / Treatment: Dietary supplement: Aminoacid supplementation; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amelia Brunani, MD; Phone Number: 390323514232; Email: brunani@auxologico.it

Study Locations

• Italy
  • Verbania
    • Oggebbio, Verbania, Italy, 28921
      • Recruiting
      • Istituto Auxologico Italiano, Site Piancavallo
      • Contact: Amelia Brunani, MD; Phone Number: 390323514232; Email: brunani@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aminoacids; Patients with obesity treated with essential aminoacids (EAA-AC)	Dietary supplement: Aminoacid supplementation; Low-calorie and low-protein diet + with 4 sachets of EEA-AC supplement per day for 2 weeks; Other Names: Controls; EAA-AC
Placebo Comparator: Control; Patients with obesity treated with placebo	Dietary supplement: Placebo; Low-calorie and low-protein diet + placebo for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Muscle mass during weight loss
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: 31J301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No