Trial document





This trial has been registered retrospectively.
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  DRKS00008181

Trial Description

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Title

Level of brain-derived neurotrophic factor during
Ramadhan fasting in Germany

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Trial Acronym

FBDNF

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URL of the Trial

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Brief Summary in Lay Language

Fasting in Ramadhan for all healthy adult muslims is an obligatory duty. This fasting month consisted of 29 or 30 days. During this month no food, drink, smoking, sex, medications, inhalation or intravenous nutritional fluids are permitted from dawn to sunset, but these are allowed at night. For the exact timing, the beginning and end of the fast each day vary according to the date and geographical location. In Germany, particularly, in Hannover the 1st Ramadan 2015 may start at about 2:45 and end at about 21:45 and will change every day according to the dawn and sunset time.
For muslims, fasting is not perceived as a corporal punishment, but a blessing with many rewards, particularly spiritual. It has been known that this is also practiced not only in Islamic culture, but also in other religions and cultures around the world since many years. The possible benefits of fasting to health have been noted, including mood enhancement and increased vigilance.
In this study we would like to know how the effect of Ramadhan fasting and its correlation with measure one of molecules that related to mood, it is called brain-derived neurotrophic factor (BDNF).
This study will have two groups. One group will do fasting in Ramadhan (fasting group), the other group (control) will not do fasting. Healthy volunteers will be recruited (mostly students from Hannover Medical school) for both group. To be eligible to the fasting group, participants have to: (1) healthy (especially free of pain and psychiatric disorders), (2) be a male gender, (3) older than 18 years of age, (4) be planning to fast the whole month of Ramadan (5) The subjects will not do Ramadhan fasting for the first experience in their life (6) understand German/English language. For control group, all subjects should meet the criteria of fasting group, except that they will not do fasting.
In fasting group, there will be 4 time points: one week before Ramadhan, in the mid of Ramadhan, in the end of Ramadhan, and one week after Ramadhan. Meanwhile, in control group there will be only 2 time points: one week before Ramadhan and in the end of Ramadhan.
From these two groups, we will take blood and analyze the level of BDNF from serum. Additionally, they will be asked to fill in questionnaires related to health-related quality of life.

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Brief Summary in Scientific Language

Brain-derived neurotrophic factor (BDNF) is one of neurotrophins that plays a role in different type of function related to neuronal systems. Many types of neurological diseases related (at least some part) to this factor (e.g. major depressive disorders, Parkinson’s disease, chronic pain, etc).
Some reports have shown the effect of calories intake on BDNF. Studies focused on different groups of patients (metabolic syndrome, schizophrenia).
Although some reports have shown the role/mechanism/correlation of BDNF and fasting, however there is no report regarding fasting in Ramadan and its correlation with the level of BDNF, especially in Germany which has longer period of fasting during summer time. Therefore we will recruit healthy subject and do a prospective study to observe the association of Ramadhan fasting and BDNF. This study will have two groups. One group will do fasting in Ramadhan (fasting group), the other group (control) will not do fasting. Healthy volunteers will be recruited (mostly students from Hannover Medical school) for both group. To be eligible to the fasting group, participants have to: (1) healthy (especially free of pain and psychiatric disorders), (2) be a male gender, (3) older than 18 years of age, (4) be planning to fast the whole month of Ramadan (5) The subjects will not do Ramadhan fasting for the first experience in their life (6) understand German/English language. For control group, all subjects should meet the criteria of fasting group, except that they will not do fasting.
In fasting group, there will be 4 time points: one week before Ramadhan, in the mid of Ramadhan, in the end of Ramadhan, and one week after Ramadhan. Meanwhile, in control group there will be only 2 time points: one week before Ramadhan and in the end of Ramadhan.
As improvement and vitality have been reported, it is hypothesized that BDNF will be changed during fasting period. Secondly, it will be proven if this will be relevant to the mood and pain thresholds.
From these two groups, we will take blood and analyze the level of BDNF from serum. Additionally, they will be asked to fill in questionnaires related to health-related quality of life.

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Organizational Data

  •   DRKS00008181
  •   2015/07/13
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  •   yes
  •   Approved
  •   6899, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy participants
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Interventions/Observational Groups

  •   One group will do fasting in Ramadhan (fasting group) for one month
  •   the other group (control) will not do fasting.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

BDNF will bemeasured from serum samples by method of enzyme-linked immunosorbent assay (ELISA).
In the fasting group, it will be measured at four time points. The first end point of the study (T1) will be conducted one week before the start of the Ramadan (June 2015). The second session will be conducted on the mid of Ramadan (T2). The third session will be conducted on the last days (T3). Explorative time point will be done at one week after the Ramadan fasting finished (T4).
In the control group, there will only be 2 time points for measuring BDNF. It will be before start of the Ramadhan (T1) and on the last days of Ramadhan (T3).

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Secondary Outcome

Body composition, Pain intensity (visual analogue scale), fatigue (visual analogue scale).

Health related quality of life will be measured by Short-Form-12.

Mood related disoreders will be measured by Beck's depression inventory and Hospital and anxiety depression scale,

Sleep related quality will be measured by epworth sleepiness scale.

In the fasting group, all end points will be measured at four time points. The first end point of the study (T1) will be conducted one week before the start of the Ramadan (June 2015). The second session will be conducted on the mid of Ramadan (T2). The third session will be conducted on the last days (T3). Explorative time point will be done at one week after the Ramadan fasting finished (T4).
In the control group, there will only be 2 time points for measuring endpoints. It will be before start of the Ramadhan (T1) and on the last days of Ramadhan (T3).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/06/09
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

(1) healthy (especially free of pain and psychiatric disorders), (2) be a male gender, (3) older than 18 years of age, (4) be planning to fast the whole month of Ramadan (5) The subjects will not do Ramadhan fasting for the first experience in their life (6) understand German/English language.

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Exclusion Criteria

If you are suffering from cancer, cardiac disease, depression, acute or inflammatory diseases, diabetes or fresh injuries we are sorry for not being able to recruit you as volunteer/participants.

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Addresses

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    • Dept. Rehabilitation Medicine, Hannover Medical School
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Klinik für RehabilitationsmedizinMedizinische Hochschule Hannover
    • Mr.  Dr.  Boya  Nugraha 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Klinik für Rehabilitationsmedizin, Hannover Medical School
    • Ms.  Samaneh  Khoshandam Ghashang 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für RehabilitationsmedizinMedizinische Hochschule Hannover
    • Mr.  Prof. Dr.  Christoph  Gutenbrunner 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/29
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.