The primary endpoint of this study is to determine whether cycles of short term FMD exposure to a fasting-mimicking diet is effective in reducing total cholesterol levels.
Age ≥ 18 years
WHO performance status score 0-2
Early stage breast cancer, ER positive, receiving an adjuvant endocrine treatment with aromatase inhibitor
Hypercholesterolemic (total cholesterol >200mg/dL)
Underweight (BMI < 18.5 kg/m2)
Current or past eating disorders identified with the SCOFF Questionnaire (Useful Eating Disorder screening questions) [19]
Malnutrition Universal Screening Tool (MUST). It considers body mass index, weight change and acute disease effect equally and determines a malnutrition risk score. A score ≥1 identify a patient at moderate risk of malnutrition;
Treatment with any investigational or non-registered drug other than the study product(s) within 30 days preceding the first dose of study product, or planned use during the study period
Parallel
FASTING-MIMICKING DIET PROGRAM
Dietary supplementNutritional intervention via fasting-mimicking diet. Patients receiving adjuvant therapy with aromatase inhibitors will be randomized 1:1 into two arms: one intervention, where will receive nutritional counseling and the study diet for 5 days each month for 6 months,and a control one, where they will receive only nutritional counseling.
Fasting-mimicking diet
Determination of number of cycles of short term FMD exposure to a fasting-mimicking diet in reducing total cholesterol levels
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