Metabolic Effects of a Diet Replaced With Essential Amino Acids

Not Applicable

Recruiting

• Conditions: Weight Loss; Obesity Morbid
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Aminoacid supplementation

• Registration Number: NCT06309563
• Lead Sponsor: Istituto Auxologico Italiano

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Obesity (BMI >35kg/m2)

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Patients with obesity treated with placebo
Aminoacids	Aminoacid supplementation	Patients with obesity treated with essential aminoacids (EAA-AC)

Primary Outcome Measures

Name	Time	Method
Muscle mass	At baseline and at 2 weeks after start of intervention	Change in muscle mass during weight loss assessed through changes in body composition

Secondary Outcome Measures

Name	Time	Method
6 minute walking test (6MWT)	At baseline and at 2 weeks after start of intervention	Change in distance covered in 6 minutes of walking during weight loss

Trial Locations

Locations (1)

Istituto Auxologico Italiano, Site Piancavallo; 🇮🇹 Oggebbio, Verbania, Italy