NCT06309563

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Aug 2023Dec 2026

Study Start

First participant enrolled

August 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

March 7, 2024

Last Update Submit

March 26, 2026

Conditions

Weight LossObesity Morbid

Keywords

Muscle mass during weight loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 6 minute walking test (6MWT)

    At baseline and at 2 weeks after start of intervention

Study Arms (2)

Aminoacids

ACTIVE COMPARATOR

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

Dietary Supplement: Aminoacid supplementation

Control

PLACEBO COMPARATOR

Patients with obesity treated with placebo

Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

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

Control
Aminoacid supplementationDIETARY_SUPPLEMENT

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

Also known as: EAA-AC, Controls
Aminoacids

Eligibility Criteria

Age45 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Obesity (BMI \>35kg/m2)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28921, Italy

RECRUITING

Related 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.

    PMID: 15545607BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Central Study Contacts

Amelia Brunani, MD

CONTACT

390323514232brunani@auxologico.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 13, 2024

Study Start

August 30, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)