RESUMO
BACKGROUND: Ramadan fasting has seen increased attention in research, often with inconsistent findings. This study aims to investigate whether dietary and lifestyle modifications during Ramadan can improve well-being and health in healthy adult Muslims. METHOD: A randomised controlled trial with two parallel groups was conducted in an outpatient clinic of a university hospital in Essen, Germany, in 2016. Healthy adult Muslims (n = 114) aged 18-60 years were randomised to a modified fasting group; i.e., they received educational material prompting dietary and lifestyle modifications pre-Ramadan, and a control group who undertook Ramadan fasting as usual. Primary outcome was quality of life (WHO-5 Well-Being Index). Secondary outcomes included sleep quality, spirituality, and mindfulness (all self-report), body weight, body mass index, body fat, waist circumference, hip circumference, blood pressure, and heart rate, as well as blood serum biomarkers. Safety was examined via adverse events. RESULTS: The modified fasting group reported significantly higher quality of life (WHO-5) compared to the control after Ramadan (MD 5.9; 95% CI, 0.02-11.8; p < 0.05). Group differences in favour of the modified fasting were also found for satisfaction with health (MD 5.9, 95% CI 0.19-11.67), ease of life (MD 4.1, 95% CI 0.38-7.80) and mindfulness (MD 7.6, 95% CI 2.68-12.52), reductions in weight (MD, - 0.9 kg; 95% CI - 1.39 to - 0.42), BMI (MD - 0.3 kg/m2, 95% CI - 0.50 to - 0.15), hip circumference (MD - 0.3 kg/m2, 95% CI - 0.50 to - 0.15), and diastolic blood pressure (MD - 2.8 mmHg, 95% CI - 5.15 to - 0.43). About 60% of participants reported adverse events, mostly headaches/migraines, dizziness/fatigue, common cold, and gastrointestinal symptoms, with no group differences. One serious non-related adverse event each occurred in both groups. CONCLUSION: Pre-Ramadan dietary and lifestyle advice can lead to short-term improvements in mental and physical well-being of adult Muslims observing Ramadan. As such, this study demonstrates the potential benefits of culturally appropriate health interventions in a religious context. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier NCT02775175).