The Influence of a Modified Ramadan Fasting Regimen on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
In this study the investigators will test the impact of a modified Ramadan Fasting regimen on health and well-being. The 2016 Ramadan is around summer solstice in Germany making it one of the most challenging fasting periods for participating Muslims. The modified Ramadan Fasting consists of educational components around fasting, and advice for nutritional modifications in order to support health and well-being during Ramadan, while the control group will continue to fast as usual. The investigators will measure not only body weight/fat but also include measures of psychological well-being, and spiritual practice, and serum markers for blood lipids, and blood sugar. With this trial the investigators aim to determine, whether such modifications around Ramadan will be beneficial for health and well-being.
详细描述
see above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Muslims participating in Ramadan Fasting
- •No first time fasting
排除标准
- •Untreated or malign hypertension
- •Eating disorder
- •psychological disorder (e.g. depression, schizophrenia, addiction)
- •co-morbid disease (e.g. diabetes, cancer, gout)
- •pregnancy
- •breastfeeding women
- •BMI under 20 or above 40
- •recently on a diet
研究组 & 干预措施
Fasting as Usual
This group will continue to practice their usual fasting regimen during Ramadan
Modified Ramadan Fasting
This group will receive an educational intervention providing knowledge about fasting and its effects on the body/mind, and health advice around nutrition to support health and well-being of participants during Ramadan.
干预措施: Modified Ramadan Fasting (Behavioral)
结局指标
主要结局
Quality of life
时间窗: 4 weeks
Quality of life, measured by the WHO-5 (World Health Organisation, Allgaier et al., 2011, WHO-5, 1998) WHO-5, Fragebogen zum Wohlbefinden (Version 1998), Psychiatric Research Unit, WHO Collaborating Centre in Mental Health, http://www.who-5.org/.
次要结局
- Quality of life(16 weeks)
- Satisfaction with life(12 weeks)
- Spirituality(12 weeks)
- Sleep quality(12 weeks)
- Mindfulness(12 weeks)
- Inner Peace(12 weeks)
- Ease of life(12 weeks)
- Body weight(12 weeks)
- Body fat(12 weeks)
- Waist circumference(12 weeks)
- Hip circumference(12 weeks)
- Compliance(4 weeks)
- Blood pressure(12 weeks)
- Heart rate(12 weeks)
- Adverse events(4 weeks)
- Blood lipid level(4 weeks)
- Blood glucose level(4 weeks)
- AST/SGOT(4 weeks)
- ALT/SGPT(4 weeks)
- GGT(4 weeks)
- Uric acid level(4 weeks)
- Creatinine(4 weeks)
- Satisfaction with life(4 weeks)
- Spirituality(4 weeks)
- Sleep quality(4 weeks)
- Hip circumference(4 weeks)
- Blood pressure(4 weeks)
- Mindfulness(4 weeks)
- Inner Peace(4 weeks)
- Ease of life(4 weeks)
- Body weight(4 weeks)
- Body fat(4 weeks)
- Waist circumference(4 weeks)
- Heart rate(4 weeks)
研究者
Romy Lauche
Principle Investigator
Universität Duisburg-Essen