Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, 45276, Germany
NCT Number: NCT02775175
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Essen, 45276, Germany
see above
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention aims to provide 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.
Time frame: 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/.
Time frame: 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/.
Time frame: 4 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: 171-177
Time frame: 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: 171-177
Time frame: 4 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):28-38
Time frame: 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):28-38
Time frame: 4 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.
Time frame: 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.
Time frame: 4 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, 7:1
Time frame: 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, 7:1
Time frame: 4 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.
Time frame: 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.
Time frame: 4 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.
Time frame: 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.
Time frame: 4 weeks
Body weight in kg
Time frame: 12 weeks
Body weight in kg
Time frame: 4 weeks
Body fat, measured using a Bioelectrical impedance analysis scale
Time frame: 12 weeks
Body fat, measured using a Bioelectrical impedance analysis scale
Time frame: 4 weeks
Waist circumference in cm
Time frame: 12 weeks
Waist circumference in cm
Time frame: 4 weeks
Hip circumference
Time frame: 12 weeks
Hip circumference
Time frame: 4 weeks
Blood pressure, measured using an automatic device
Time frame: 12 weeks
Blood pressure, measured using an automatic device
Time frame: 4 weeks
Heart rate, measured using an automatic device
Time frame: 12 weeks
Heart rate, measured using an automatic device
Time frame: 4 weeks
Compliance, measured using a structured interview about nutrition during Ramadan
Time frame: 4 weeks
adverse events during the study period
Time frame: 4 weeks
Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol
Time frame: 4 weeks
Blood glucose level, serum measure
Time frame: 4 weeks
AST/SGOT, as measure of liver function
Time frame: 4 weeks
ALT/SGPT, as measure of liver function
Time frame: 4 weeks
GGT, as measure of liver function
Time frame: 4 weeks
Uric acid level, serum measure
Time frame: 4 weeks
Creatinine level, serum measure
Universität Duisburg-Essen
Other
The Influence of a Modified Ramadan Fasting Regimen on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
Acronym: Ramadan_16
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05995119
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Las Vegas, Nevada, United States
View Trial DetailsNCT02253056
Behavior, Fasting
Berlin, State of Berlin, Germany
View Trial DetailsNCT07638696
Autophagy, Behavior
Nicosia, Cyprus
View Trial DetailsNCT05545306
Behavior, Body Weight
Phoenix, Arizona, United States
View Trial Details