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Completed

NCT Number: NCT02775175

Influence of a Modified Ramadan Fasting 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, 45276, Germany

About this study

see above

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Ramadan Fasting

Behavioral

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.

Primary outcomes

  1. Quality of life

    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/.

Secondary outcomes

  1. Quality of life

    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/.

  2. Satisfaction with life

    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

  3. Satisfaction with life

    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

  4. Spirituality

    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

  5. Spirituality

    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

  6. Sleep quality

    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.

  7. Sleep quality

    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.

  8. Mindfulness

    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

  9. Mindfulness

    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

  10. Inner Peace

    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.

  11. Inner Peace

    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.

  12. Ease of life

    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.

  13. Ease of life

    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.

  14. Body weight

    Time frame: 4 weeks

    Body weight in kg

  15. Body weight

    Time frame: 12 weeks

    Body weight in kg

  16. Body fat

    Time frame: 4 weeks

    Body fat, measured using a Bioelectrical impedance analysis scale

  17. Body fat

    Time frame: 12 weeks

    Body fat, measured using a Bioelectrical impedance analysis scale

  18. Waist circumference

    Time frame: 4 weeks

    Waist circumference in cm

  19. Waist circumference

    Time frame: 12 weeks

    Waist circumference in cm

  20. Hip circumference

    Time frame: 4 weeks

    Hip circumference

  21. Hip circumference

    Time frame: 12 weeks

    Hip circumference

  22. Blood pressure

    Time frame: 4 weeks

    Blood pressure, measured using an automatic device

  23. Blood pressure

    Time frame: 12 weeks

    Blood pressure, measured using an automatic device

  24. Heart rate

    Time frame: 4 weeks

    Heart rate, measured using an automatic device

  25. Heart rate

    Time frame: 12 weeks

    Heart rate, measured using an automatic device

  26. Compliance

    Time frame: 4 weeks

    Compliance, measured using a structured interview about nutrition during Ramadan

  27. Adverse events

    Time frame: 4 weeks

    adverse events during the study period

  28. Blood lipid level

    Time frame: 4 weeks

    Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol

  29. Blood glucose level

    Time frame: 4 weeks

    Blood glucose level, serum measure

  30. AST/SGOT

    Time frame: 4 weeks

    AST/SGOT, as measure of liver function

  31. ALT/SGPT

    Time frame: 4 weeks

    ALT/SGPT, as measure of liver function

  32. GGT

    Time frame: 4 weeks

    GGT, as measure of liver function

  33. Uric acid level

    Time frame: 4 weeks

    Uric acid level, serum measure

  34. Creatinine

    Time frame: 4 weeks

    Creatinine level, serum measure

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Acronym: Ramadan_16

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 17, 2016
Registry last updated
May 2, 2018

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.

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