Biological and Psychological Health Effect of Ramadan Study (HERS)
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| ClinicalTrials.gov Identifier: NCT04846075 |
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Recruitment Status :
Recruiting
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
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Sponsor:
Bastyr University
Information provided by (Responsible Party):
Masa Sasagawa, ND, PhD, Bastyr University
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Brief Summary:
This observational study collects data on blood neurotransmitter and neuromodulator levels of subjects observing Ramadan. Additional information collected are a diet record, mood and perceived stress using validated surveys at three time points: a) before starting Ramadan, b) at the midpoint evaluation, and c) at the end of Ramadan. Three additional dispositional factors collected at the beginning and at the end are: a) sense of belonging, b) purpose in life (sense of coherence), and c) empathy (interpersonal reactivity index). The subjects are also individually interviewed on their experience of Ramadan as narrative data.
| Condition or disease | Intervention/treatment |
|---|---|
| Quality of Life | Behavioral: Ramadan fasting, praying, and welfare for poor |
This is an observational study seeking research volunteers during Ramadan in the Pacific Northwest. We plan to recruit 10 female and 5 male volunteers. Each subject will donate her/his blood (20 milliliters) at three time points: a) before initiation of Ramadan, b) 14 days later, and c) 30 days later (60 milliliters total over one month). Because the dates of Ramadan in 2021 occur on April 12th through May 11th, the three days of the blood collection will be April 10th, April 27th and May 11th ± 1 day. Due to current COVID-19 restrictions, mass gatherings at mosque do not happen. This study deploys a mobile phlebotomist who is a licensed healthcare practitioner who will set up a droplet barrier phlebotomy station. The time of phlebotomy is determined based on the hydration status of each individual. The specimens will be packed in an ice cooler and processed (centrifuged and divided into aliquots) at Bastyr University Tierney laboratory and stored in a -80 degree Celsius freezer until analyzed at the same time for the three time points. Narrative data will also be collected through individual conversations (phone or in-person) at the completion of Ramadan, reflecting on the study and any heightened sense of spirituality.
| Study Type : | Observational |
| Estimated Enrollment : | 15 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Effect of Ramadan on the Blood Concentration of Serotonin, Dopamine, Brain-Derived Neurotorophic Factor and Nerve Growth Factor: A Replication Study |
| Actual Study Start Date : | April 8, 2021 |
| Estimated Primary Completion Date : | May 15, 2021 |
| Estimated Study Completion Date : | June 30, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Ramadan Group
Diurnal fasting and spiritual practices. Operationally assessed by the level of compliance to Sawm, Salat, and Zakat.
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Behavioral: Ramadan fasting, praying, and welfare for poor
Abstaining from food, drink, smoking, and sexual activity duirng daytime; ritualistic praying at specific time of a day for five or more times; volunteering for communities or donation
Other Name: Diurnal fasting or Sawm; five or more prayers or Salat; donation or volunteering or Zakat |
Primary Outcome Measures :
- Change in dopamine concentration [ Time Frame: 0 to 30 days ]Plasma dopamine level pg/mL
- Change in serotonin concentration [ Time Frame: 0 to 30 days ]Plasma serotonin level ng/mL
- Change in Brain-Derived Neurotrophic factor (BDNF) concentration [ Time Frame: 0 to 30 days ]Plasma BDNF level pg/mL
- Change in Nerve Growth Factor (NGF) concentration [ Time Frame: 0 to 30 days ]Plasma NGF level pg/mL
Secondary Outcome Measures :
- Change in mood measured by Positive And Negative Affect Scale (PANAS) [ Time Frame: 0 to 30 days ]PANAS questionnaire in English
- Change in perceived stress level measured by Weekly Stress Inventory (WSI) [ Time Frame: 0 to 30 days ]Weekly Stress Inventory in English
Biospecimen Retention: Samples Without DNA
10 mL serum (SST) and 10 mL (plasma) EDTA
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Upon obtaining permission from the community leaders (Muslim Association of Puget Sound) and support from IMAN Center of Kirkland, flyers will be disseminated through friends and family members of Muslim members. Anyone who observes Ramadan for religious or health reasons, and who are also committed to following the fasting as prescribed, and who do not have chronic health conditions, will be eligible for participation in this study.
Criteria
Inclusion Criteria:
- Male or female ≥ 18 years of age at the time of baseline blood draw, up to 65 years old
- Community member who observe Ramadan during April 12 (Monday evening) through May 11, 2021 (Tuesday sundown)
- Understand and sign the informed consent form and have ability to comply with the requiremnets of the study
- Vaccinated for COVID or having a history of a positive PCR test which was resolved
Exclusion Criteria:
- Anticubital vein is not accessible
- Pregnant, breastfeeding, recovering from major illness or surgery that influences quality of life
- Who reside more than 14 miles away from the city limits
- Unavailable to meet in-person and donate blood for any of three measurement days (basline, 15th day, post Ramadan)
- Smoking, drinking aclohol or using recreational drug
- Presence of a condition that in the opinon of the Investigator would compromise the safety of the participant or the quality of the data
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846075
Contacts
| Contact: Masa Sasagawa, ND, PhD | 425-602-3164 | msasagawa@bastyr.edu | |
| Contact: Paul Amieux, PhD | 425-602-3132 | pamieux@bastyr.edu |
Locations
| United States, Washington | |
| Bastyr University | Recruiting |
| Kenmore, Washington, United States, 98028 | |
| Contact: Masa Sasagawa, ND, PhD 425-602-3164 msasagawa@bastyr.edu | |
Sponsors and Collaborators
Bastyr University
Investigators
| Principal Investigator: | Masa Sasagawa, ND, PhD | Bastyr University |
| Responsible Party: | Masa Sasagawa, ND, PhD, Assistant Research Scientist, Bastyr University |
| ClinicalTrials.gov Identifier: | NCT04846075 |
| Other Study ID Numbers: |
21-1690 |
| First Posted: | April 15, 2021 Key Record Dates |
| Last Update Posted: | April 15, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Data are collected by subject IDs (SIDs). Only aggregate results will be available |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |