Effect of modified alternate day fasting diet on the severity of premenstrual syndrome and health-related quality of life in women with overweight or obesity: a trial study protocol

INTRODUCTION: Premenstrual syndrome (PMS) includes a range of physical, behavioural and psychological symptoms and decreases women’s health-related quality of life (HRQoL). It has been proposed that increased body mass index (BMI) is associated with menstrual problems and decreased HRQoL. The body fat amount plays a role in menstrual cycles by altering the oestrogen/progesterone ratio. Alternate day fasting as an unusual diet results in the improvement of anthropometric indices and reduction of body weight. This study aims to investigate the effect of a daily calorie restriction diet and a modified alternate day fasting diet on PMS and HRQoL. METHODS AND ANALYSIS: This 8-week open-label parallel randomised controlled trial examines the impact of a modified alternate-day fasting diet and daily caloric restriction on the severity of PMS and HRQoL in obese or overweight women. Using simple random sampling, women between the ages of 18 years and 50 years and 25 ≤ BMI ˂ 40 who meet the inclusion and exclusion criteria will be chosen from the Kashan University of Medical Sciences Centre. Patients will be randomised, based on BMI and age through stratified randomisation. Then by the random numbers table, they are allocated to fasting (intervention) or daily calorie restriction (control) groups. Outcomes are chosen for the trial: the difference in the severity of PMS, HRQoL, BMI, body fat mass, fat-free mass, waist-to-hip ratio, waist circumference, hip circumference, per cent body fat, skeletal muscle mass and visceral fat area from baseline to 8 weeks. ETHICS AND DISSEMINATION: The Kashan University of Medical Sciences Ethics Committee has approved the trial (IR.KAUMS.MEDNT.REC.1401.003) (17 April 2022). Results will be published in peer-reviewed academic journals and the participants will be informed via phone calls. TRIAL REGISTRATION NUMBER: IRCT20220522054958N1.