NCT02775175

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

May 14, 2016

Last Update Submit

April 30, 2018

Conditions

Healthy Volunteers

Keywords

RamadanFastingNutritionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (34)

  • Quality of life

    16 weeks

  • Satisfaction with life

    4 weeks

  • Satisfaction with life

    12 weeks

  • Spirituality

    4 weeks

  • Spirituality

    12 weeks

  • +29 more secondary outcomes

Study Arms (2)

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.

Behavioral: Modified Ramadan Fasting

Interventions

Modified Ramadan FastingBEHAVIORAL

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.

Modified Ramadan Fasting

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Muslims participating in Ramadan Fasting
  • No first time fasting

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, 45276, Germany

Location

Related Publications (2)

  • 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

    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.

    PMID: 38777939DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Gustav Dobos, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 14, 2016

First Posted

May 17, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

DE(1)