Healthy VolunteersRamadan_16NCT02775175
Influence of a Modified Ramadan Fasting on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
A study testing Modified Ramadan Fasting in people with Healthy Volunteers, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Modified Ramadan Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Muslims participating in Ramadan Fasting
- No first time fasting
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, 45276
About this study
Official title: 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.
Read the detailed description
see above
- Conditions
- Healthy Volunteers
- Being tested
- Modified Ramadan Fasting
- Keywords
- Ramadan, Fasting, Nutrition, Quality of Life
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Ramadan FastingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting as Usual | No intervention | This group will continue to practice their usual fasting regimen during Ramadan |
| Modified Ramadan Fasting | Experimental | 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. Receives: Behavioral: Modified Ramadan Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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/.
Measured: 4 weeks
Secondary outcomes (34)
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/.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Body weight
Body weight in kg
Measured: 4 weeks
Body weight
Body weight in kg
Measured: 12 weeks
Body fat
Body fat, measured using a Bioelectrical impedance analysis scale
Measured: 4 weeks
Body fat
Body fat, measured using a Bioelectrical impedance analysis scale
Measured: 12 weeks
Waist circumference
Waist circumference in cm
Measured: 4 weeks
Waist circumference
Waist circumference in cm
Measured: 12 weeks
Hip circumference
Hip circumference
Measured: 4 weeks
Hip circumference
Hip circumference
Measured: 12 weeks
Blood pressure
Blood pressure, measured using an automatic device
Measured: 4 weeks
Blood pressure
Blood pressure, measured using an automatic device
Measured: 12 weeks
Heart rate
Heart rate, measured using an automatic device
Measured: 4 weeks
Heart rate
Heart rate, measured using an automatic device
Measured: 12 weeks
Compliance
Compliance, measured using a structured interview about nutrition during Ramadan
Measured: 4 weeks
Adverse events
adverse events during the study period
Measured: 4 weeks
Blood lipid level
Blood lipid level, including serum measures triglycerides, cholesterol, HDL and LDL cholesterol
Measured: 4 weeks
Blood glucose level
Blood glucose level, serum measure
Measured: 4 weeks
AST/SGOT
AST/SGOT, as measure of liver function
Measured: 4 weeks
ALT/SGPT
ALT/SGPT, as measure of liver function
Measured: 4 weeks
GGT
GGT, as measure of liver function
Measured: 4 weeks
Uric acid level
Uric acid level, serum measure
Measured: 4 weeks
Creatinine
Creatinine level, serum measure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, MD, Study director, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775175
- Sponsor's protocol ID
- 15-6336-BO
- Acronym
- Ramadan_16
- Status last verified
- Apr 2018
- First submitted
- 14 May 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Lauche R, Fathi I, Saddat C, Klose P, Al-Abtah J, Bussing A, Rampp T, Dobos G, Cramer H. Effects of Modified Ramadan Fasting on Mental Well-Being and Biomarkers in Healthy Adult Muslims - A Randomised Controlled Trial. Int J Behav Med. 2025 Dec;32(6):953-968. doi: 10.1007/s12529-024-10296-0. Epub 2024 May 22.
PubMed 38777939
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Modified Ramadan Fasting Regimen on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02775175
- Acronym / sponsor ID
- Ramadan_16 / 15-6336-BO
- Conditions
- Healthy Volunteers
- Keywords
- Ramadan, Fasting, Nutrition, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting as Usual | No intervention | –This group will continue to practice their usual fasting regimen during Ramadan |
| Modified Ramadan Fasting | Experimental | Behavioral: Modified Ramadan FastingThis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Muslims participating in Ramadan Fasting
- No first time fasting
Key exclusion criteria (8 listed)
- Untreated or malign hypertension
- Eating disorder
- psychological disorder (e.g. depression, schizophrenia, addiction)
- co-morbid disease (e.g. diabetes, cancer, gout)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Ramadan FastingThe 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. | Behavioural | Modified Ramadan Fasting |
Primary outcome
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/.
34 secondary outcomes
Quality of life
Time frame: 16 weeks
Satisfaction with life
Time frame: 4 weeks
Satisfaction with life
Time frame: 12 weeks
Spirituality
Time frame: 4 weeks
Spirituality
Time frame: 12 weeks
Sleep quality
Time frame: 4 weeks
Sleep quality
Time frame: 12 weeks
Mindfulness
Time frame: 4 weeks
Mindfulness
Time frame: 12 weeks
Inner Peace
Time frame: 4 weeks
Inner Peace
Time frame: 12 weeks
Ease of life
Time frame: 4 weeks
Ease of life
Time frame: 12 weeks
Body weight
Time frame: 4 weeks
Body weight
Time frame: 12 weeks
Body fat
Time frame: 4 weeks
Body fat
Time frame: 12 weeks
Waist circumference
Time frame: 4 weeks
Waist circumference
Time frame: 12 weeks
Hip circumference
Time frame: 4 weeks
Hip circumference
Time frame: 12 weeks
Blood pressure
Time frame: 4 weeks
Blood pressure
Time frame: 12 weeks
Heart rate
Time frame: 4 weeks
Heart rate
Time frame: 12 weeks
Compliance
Time frame: 4 weeks
Adverse events
Time frame: 4 weeks
Blood lipid level
Time frame: 4 weeks
Blood glucose level
Time frame: 4 weeks
AST/SGOT
Time frame: 4 weeks
ALT/SGPT
Time frame: 4 weeks
GGT
Time frame: 4 weeks
Uric acid level
Time frame: 4 weeks
Creatinine
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- BackgroundLauche 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
- Derived from this study: PubMed 38777939Lauche R, Fathi I, Saddat C, Klose P, Al-Abtah J, Bussing A, Rampp T, Dobos G, Cramer H. Effects of Modified Ramadan Fasting on Mental Well-Being and Biomarkers in Healthy Adult Muslims - A Randomised Controlled Trial. Int J Behav Med. 2025 Dec;32(6):953-968. doi: 10.1007/s12529-024-10296-0. Epub 2024 May 22.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Dobos, MD study director
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Ramadan Fasting in people with Healthy Volunteers, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775175, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.