"Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation, SIDERALE"

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 29, 2023

Primary Completion Date

October 29, 2025

Study Completion Date

October 29, 2026

Conditions
ObesityType2diabetesLipodystrophyInfectionsObesity Associated Disorder
Interventions
DIETARY_SUPPLEMENT

Mediterranean diet

Hypocaloric Mediterranean Diet consist of a nutritional regimen with customized daily energy intake, calculated considering the Basal Metabolism and Physical Activity Level (LAF) of each patient. The distribution of macronutrients will be worked out as follows: ≃ 55-60% Carbohydrates (of which 80% are complex carbohydrates, pasta, bread, rice, whole grains and 20% simple sugars), ≃ 10-15% Proteins (of which the 60% of animal origin (meat, especially white) and 40% of vegetable origin (beans, chickpeas, lentils and legumes in general), ≃ 25-30% of lipids (predominantly olive oil).

DIETARY_SUPPLEMENT

Melatonin supplementation

Melatonin (supplement formulation in capsules, 1mg/die one hour before sleep) will be associated with mediterranean diet for 12 w.

Trial Locations (4)

28100

RECRUITING

Università del Piemonte Orientale, Novara

56126

RECRUITING

University of Pisa, Pisa

80131

RECRUITING

"Federico II University of Naples, Department of Clinical and Molecular Endocrinology and Oncology", Naples

00161

RECRUITING

"Sapienza University of Rome", Roma

All Listed Sponsors
collaborator

University of Roma La Sapienza

OTHER

collaborator

University of Pisa

OTHER

collaborator

Università degli Studi del Piemonte Orientale Amedeo Avogadro

OTHER

collaborator

University of Rome Foro Italico

OTHER

lead

Federico II University

OTHER