Influence of a Modified Ramadan Fasting on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial (Ramadan_16)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Behavioral: Modified Ramadan Fasting

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45276
    • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Fasting as Usual; This group will continue to practice their usual fasting regimen during Ramadan
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight in kg	12 weeks
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
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
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
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
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
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
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
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
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
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
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
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
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
Body weight	Body weight in kg	4 weeks
Body fat	Body fat, measured using a Bioelectrical impedance analysis scale	4 weeks
Body fat	Body fat, measured using a Bioelectrical impedance analysis scale	12 weeks
Waist circumference	Waist circumference in cm	4 weeks
Waist circumference	Waist circumference in cm	12 weeks
Hip circumference	Hip circumference	4 weeks
Hip circumference	Hip circumference	12 weeks
Blood pressure	Blood pressure, measured using an automatic device	4 weeks
Blood pressure	Blood pressure, measured using an automatic device	12 weeks
Heart rate	Heart rate, measured using an automatic device	4 weeks
Heart rate	Heart rate, measured using an automatic device	12 weeks
Compliance	Compliance, measured using a structured interview about nutrition during Ramadan	4 weeks
Adverse events	adverse events during the study period	4 weeks
Blood lipid level	Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol	4 weeks
Blood glucose level	Blood glucose level, serum measure	4 weeks
AST/SGOT	AST/SGOT, as measure of liver function	4 weeks
ALT/SGPT	ALT/SGPT, as measure of liver function	4 weeks
GGT	GGT, as measure of liver function	4 weeks
Uric acid level	Uric acid level, serum measure	4 weeks
Creatinine	Creatinine level, serum measure	4 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Study Director: Gustav Dobos, MD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 14, 2016
• First Submitted That Met QC Criteria: May 14, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; Nutrition; Fasting; Ramadan
• Other Study ID Numbers: 15-6336-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED