Clinical trial NCT04846075: Biological and Psychological Health Effect of Ramadan Study
Official title: The Effect of Ramadan on the Blood Concentration of Serotonin, Dopamine, Brain-Derived Neurotorophic Factor and Nerve Growth Factor: A Replication Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Lead sponsor: Bastyr University
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change in dopamine concentration
timeFrame: 0 to 30 days
measure: Change in serotonin concentration
timeFrame: 0 to 30 days
measure: Change in Brain-Derived Neurotrophic factor (BDNF) concentration
timeFrame: 0 to 30 days
measure: Change in Nerve Growth Factor (NGF) concentration
timeFrame: 0 to 30 days
Secondary outcomes:
measure: Change in mood measured by Positive And Negative Affect Scale (PANAS)
timeFrame: 0 to 30 days
measure: Change in perceived stress level measured by Weekly Stress Inventory (WSI)
timeFrame: 0 to 30 days
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University
state: Washington
Study officials:
affiliation: Bastyr University
name: Masa Sasagawa, ND, PhD
role: PRINCIPAL_INVESTIGATOR
References: