The effects of Ramadan fasting on physical and mental health in healthy adult Muslims—Study protocol for a randomised controlled trial

IntroductionFasting during the month of Ramadan is considered one of the five pillars of the Islamic religion, and Muslims must abstain from food and drink between dusk and dawn. Research has found that fasting during Ramadan may affect the health of Muslims. Results of those studies however are often contradictory, with quantity and composition of meals during Ramadan being potential influencing factors. In order to determine its influence on the outcomes after Ramadan fasting, this study aims to determine whether a modified healthy fasting regimen is beneficial for physical and mental health among adult Muslims.Design, methods and analysisThis is a randomised controlled trial with two parallel groups testing the superiority a modified fasting regimen compared to usual fasting during Ramadan. Healthy adult Muslims between 18 and 60 years of age, who plan to participate in Ramadan fasting, will be randomly allocated to one of two groups with a 1:1 allocation ratio. The intervention group will receive additional health advice regarding behavioural and nutritional modifications during Ramadan, the control group will conduct the Ramadan fasting as usual. Before, at the end of the Ramadan period and 12 weeks later data will be collected on participants mental and physical well-being, including quality of life (WHO-5, primary outcome), sleep quality, spirituality, mindfulness, body constitution (weight, body mass index, body fat, waist circumference, hip circumference), blood pressure and heart rate, blood lipid and glucose levels, liver enzymes, uric acid and creatinine, and adverse events.DiscussionThe trial will provide evidence if and to what extend behavioural and nutritional modifications might be beneficial for healthy Muslims undergoing Ramadan fasting. If successful this intervention might provide a valuable approach to improve the health and well-being during Ramadan fasting.Ethics and trial registrationThe trial protocol has been reviewed and approved by the Ethics Committee of the Medical Faculty of the University of Duisburg-Essen (approval number 15-6336-BO), and it is registered at ClinicalTrials.gov (Identifier: NCT02775175).