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

NCT ID: NCT02775175

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

Brief Summary

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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

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see above

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fasting as Usual

This group will continue to practice their usual fasting regimen during Ramadan

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Modified Ramadan Fasting

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Romy Lauche

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustav Dobos, MD

Role: STUDY_DIRECTOR

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Locations

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Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, , Germany

Site Status

Countries

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Germany

References

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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

Reference Type BACKGROUND

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. 2024 May 22. doi: 10.1007/s12529-024-10296-0. Online ahead of print.

Reference Type DERIVED
PMID: 38777939 (View on PubMed)

Other Identifiers

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15-6336-BO

Identifier Type: -

Identifier Source: org_study_id

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