KEtogenic Diet and Its Multiple EffectS on Obesity

Evaluation of weight loss

Weight loss expressed in Kg

Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Evaluation of changes of perceived sleep

Assessment with the questionnaires Pittsburgh Sleep Quality Index; global score on a scale from 0 to 21; the higher the score, the worse the sleep quality

Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Evaluation of changes of perceived sleepiness

Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness

Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Evaluation of changes in clock genes expression

Evaluation of the expression of the clock genes in blood cells

Time frame: At baseline, at 30 days

Evaluation of changes in hormonal profile

Assessment of hormonal parameters, as cortisol, expressed in ug/dL

Time frame: At baseline, at 30 days

Evaluation of changes in sexual function in males

Assessed with the questionnaires International Index of Erectile Function (IIEF-5); scale from 5 to 25; the higher the score, the better the erectile function

Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Evaluation of changes in inflammation

Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL

Time frame: At baseline, at 30 days, at 60 days if the patient continued the diet

Evaluation of changes of peripheral blood mononuclear cells

Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3

Time frame: At baseline, at 30 days, at 60 days if the patient continued the diet

Evaluation of changes in sleep parameters (length)

Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes

Time frame: At baseline, at 30 days

Evaluation of changes in hip circumference

Assessment of hip circumference, expressed in cm

Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Evaluation of changes in waist circumference

Assessment of waist circumference, expressed in cm

Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Change in circadian rhythm

Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours

Time frame: At baseline, at 30 days

Evaluation of changes in Sexual Function in Females

Assessed with the questionnaire Female Sexual Function Index (FSFI); scale of every item from 1 to 5; the higher score, the better the sexual function

Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Evaluation of changes in sleep efficiency

Sleep efficiency expressed as a percentage; measurement with actigraphy

Time frame: At baseline, at 30 days

Evaluation of changes in number of awakenings

Measurement with actigraphy

Time frame: At baseline, at 30 days

Evaluation of changes in sleep parameters

Evaluation of sleep fragmentation index and movement index, with actigraphy

Time frame: At baseline, at 30 days

Evaluation of changes in metabolic parameters

Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L

Time frame: At baseline, at 30 days

Evaluation of changes in BMI

Weight and height will be combined to report BMI in kg/m\^2

Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Evaluation of height

Assessment of height, expressed in cm

Time frame: At baseline

Evaluation of changes in whole blood cells gene expression

Evaluation of the changes in the expression of blood cells genes, as metabolic, inflammatory and immunological genes, with RNA-seq in whole blood cells

Time frame: At baseline, at 30 days