Clinical trial NCT02775175: Influence of a Modified Ramadan Fasting on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
Official title: The Influence of a Modified Ramadan Fasting Regimen on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Ramadan
Fasting
Nutrition
Quality of Life
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* Healthy Muslims participating in Ramadan Fasting
* No first time fasting

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of life
timeFrame: 4 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 16 weeks
measure: Satisfaction with life
timeFrame: 4 weeks
measure: Satisfaction with life
timeFrame: 12 weeks
measure: Spirituality
timeFrame: 4 weeks
measure: Spirituality
timeFrame: 12 weeks
measure: Sleep quality
timeFrame: 4 weeks
measure: Sleep quality
timeFrame: 12 weeks
measure: Mindfulness
timeFrame: 4 weeks
measure: Mindfulness
timeFrame: 12 weeks
measure: Inner Peace
timeFrame: 4 weeks
measure: Inner Peace
timeFrame: 12 weeks
measure: Ease of life
timeFrame: 4 weeks
measure: Ease of life
timeFrame: 12 weeks
measure: Body weight
timeFrame: 4 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Body fat
timeFrame: 4 weeks
measure: Body fat
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 4 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Hip circumference
timeFrame: 4 weeks
measure: Hip circumference
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Heart rate
timeFrame: 4 weeks
measure: Heart rate
timeFrame: 12 weeks
measure: Compliance
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 4 weeks
measure: Blood lipid level
timeFrame: 4 weeks
measure: Blood glucose level
timeFrame: 4 weeks
measure: AST/SGOT
timeFrame: 4 weeks
measure: ALT/SGPT
timeFrame: 4 weeks
measure: GGT
timeFrame: 4 weeks
measure: Uric acid level
timeFrame: 4 weeks
measure: Creatinine
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Study officials:
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
name: Gustav Dobos, MD
role: STUDY_DIRECTOR
References:
citation: Lauche R, Fathi I, Saddat C, Klose P, Al-Abtah J, Büssing A, Rampp T, Dobos G, Cramer H. The effects of Ramadan fasting on physical and mental health in healthy adult Muslims - Study protocol for a randomised controlled trial. Advances in Integrative Medicine, 2016, 3 (1), 26 - 30. doi: 10.1016/j.aimed.2016.07.001