100
Participants
Start Date
December 29, 2023
Primary Completion Date
October 29, 2025
Study Completion Date
October 29, 2026
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).
Melatonin supplementation
Melatonin (supplement formulation in capsules, 1mg/die one hour before sleep) will be associated with mediterranean diet for 12 w.
RECRUITING
Università del Piemonte Orientale, Novara
RECRUITING
University of Pisa, Pisa
RECRUITING
"Federico II University of Naples, Department of Clinical and Molecular Endocrinology and Oncology", Naples
RECRUITING
"Sapienza University of Rome", Roma
University of Roma La Sapienza
OTHER
University of Pisa
OTHER
Università degli Studi del Piemonte Orientale Amedeo Avogadro
OTHER
University of Rome Foro Italico
OTHER
Federico II University
OTHER