Metabolic Effects of a Diet Replaced With Essential Amino Acids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Obesity Morbid Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aminoacids

Patients with obesity treated with essential aminoacids (EAA-AC)

Group Type ACTIVE_COMPARATOR

Aminoacid supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Control

Patients with obesity treated with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Aminoacid supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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EAA-AC Controls

Eligibility Criteria

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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).

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No