Influence of a Modified Ramadan Fasting on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial

Healthy Volunteers Clinical Trial

— Ramadan_16  

Official title:

The Influence of a Modified Ramadan Fasting Regimen on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775175
• Other study ID #: 15-6336-BO
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: April 2018
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Behavioral:
• Modified Ramadan Fasting
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.

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	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/.	4 weeks
Secondary	Quality of life	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/.	16 weeks
Secondary	Satisfaction with life	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	4 weeks
Secondary	Satisfaction with life	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	12 weeks
Secondary	Spirituality	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	4 weeks
Secondary	Spirituality	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	12 weeks
Secondary	Sleep quality	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.	4 weeks
Secondary	Sleep quality	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.	12 weeks
Secondary	Mindfulness	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	4 weeks
Secondary	Mindfulness	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	12 weeks
Secondary	Inner Peace	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.	4 weeks
Secondary	Inner Peace	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.	12 weeks
Secondary	Ease of life	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.	4 weeks
Secondary	Ease of life	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.	12 weeks
Secondary	Body weight	Body weight in kg	4 weeks
Secondary	Body weight	Body weight in kg	12 weeks
Secondary	Body fat	Body fat, measured using a Bioelectrical impedance analysis scale	4 weeks
Secondary	Body fat	Body fat, measured using a Bioelectrical impedance analysis scale	12 weeks
Secondary	Waist circumference	Waist circumference in cm	4 weeks
Secondary	Waist circumference	Waist circumference in cm	12 weeks
Secondary	Hip circumference	Hip circumference	4 weeks
Secondary	Hip circumference	Hip circumference	12 weeks
Secondary	Blood pressure	Blood pressure, measured using an automatic device	4 weeks
Secondary	Blood pressure	Blood pressure, measured using an automatic device	12 weeks
Secondary	Heart rate	Heart rate, measured using an automatic device	4 weeks
Secondary	Heart rate	Heart rate, measured using an automatic device	12 weeks
Secondary	Compliance	Compliance, measured using a structured interview about nutrition during Ramadan	4 weeks
Secondary	Adverse events	adverse events during the study period	4 weeks
Secondary	Blood lipid level	Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol	4 weeks
Secondary	Blood glucose level	Blood glucose level, serum measure	4 weeks
Secondary	AST/SGOT	AST/SGOT, as measure of liver function	4 weeks
Secondary	ALT/SGPT	ALT/SGPT, as measure of liver function	4 weeks
Secondary	GGT	GGT, as measure of liver function	4 weeks
Secondary	Uric acid level	Uric acid level, serum measure	4 weeks
Secondary	Creatinine	Creatinine level, serum measure	4 weeks