Overview

This trial has been completed.

Condition healthy volunteers
Treatment modified ramadan fasting
Sponsor Universität Duisburg-Essen
Start date May 2016
End date July 2016
Trial size 114 participants
Trial identifier NCT02775175, 15-6336-BO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
This group will continue to practice their usual fasting regimen during Ramadan
(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.
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.

Primary Outcomes

Measure
Quality of life
time frame: 4 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title The Influence of a Modified Ramadan Fasting Regimen on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial
Description see above
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Universität Duisburg-Essen.