Influence of a Modified Ramadan Fasting on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
- Conditions
- Healthy Volunteers
- Interventions
- Behavioral: Modified Ramadan Fasting
- Registration Number
- NCT02775175
- Lead Sponsor
- Universität Duisburg-Essen
- Brief Summary
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.
- Detailed Description
see above
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Healthy Muslims participating in Ramadan Fasting
- No first time fasting
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modified Ramadan Fasting 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.
- Primary Outcome Measures
Name Time Method Quality of life 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/.
- Secondary Outcome Measures
Name Time Method Ease of life 12 weeks Ease of life, measured by the Emotional and rational disease acceptance questionnaire (ERDA)
Büssing A, Matthiessen PF, Mundle G. Emotional and rational disease acceptance in patients with depression and alcohol addiction. BMC Health and Quality of Life Outcomes 2008; 6:4.Body weight 12 weeks Body weight in kg
Body fat 12 weeks Body fat, measured using a Bioelectrical impedance analysis scale
Blood pressure 12 weeks Blood pressure, measured using an automatic device
Quality of life 16 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/.Satisfaction with life 12 weeks Satisfaction with life, measured by the BMLSS-10 (Brief Multidimensional Life Satisfaction Scale)
Büssing A, Fischer J, Haller A, Heusser P, Ostermann T, Matthiessen PF: Validation of the brief multidimensional life satisfaction scale in patients with chronic diseases. European Journal of Medicine Research 2009; 14: 171-177Spirituality 12 weeks Spirituality, measured by the SpREUK-P SF17 (Spiritual and Religious Attitudes in Dealing with Illness)
Büssing A, Reiser F, Michalsen A, Baumann K: Engagement of patients with chronic diseases in spiritual and secular forms of practice: Results with the shortened SpREUK-P SF17 Questionnaire. Integrative Medicine: A Clinician´s Journal 2012; 11(1):28-38Sleep quality 12 weeks Sleep quality, measured by the PROMIS Sleep Disturbances and Sleep-related impairment questionnaires
Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS™ sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24.Mindfulness 12 weeks Mindfulness, measured by the Conscious Presence and Self Control Instruments
Büssing A, Walach H, Kohls N, Zimmermann F, Trousselard M. Conscious Presence and Self Control as a measure of situational awareness in soldiers - A validation study. International Journal of Mental Health Systems 2013, 7:1Inner Peace 12 weeks Inner Peace, measured by the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp)
Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D: Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy - Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med 2002, 24:49-58.Heart rate 12 weeks Heart rate, measured using an automatic device
Waist circumference 12 weeks Waist circumference in cm
Hip circumference 12 weeks Hip circumference
Compliance 4 weeks Compliance, measured using a structured interview about nutrition during Ramadan
Adverse events 4 weeks adverse events during the study period
Blood lipid level 4 weeks Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol
Blood glucose level 4 weeks Blood glucose level, serum measure
AST/SGOT 4 weeks AST/SGOT, as measure of liver function
ALT/SGPT 4 weeks ALT/SGPT, as measure of liver function
GGT 4 weeks GGT, as measure of liver function
Uric acid level 4 weeks Uric acid level, serum measure
Creatinine 4 weeks Creatinine level, serum measure
Trial Locations
- Locations (1)
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
🇩🇪Essen, Germany