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Biological and Psychological Health Effect of Ramadan Study

The Effect of Ramadan on the Blood Concentration of Serotonin, Dopamine, Brain-Derived Neurotorophic Factor and Nerve Growth Factor: A Replication Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04846075
Acronym
HERS
Enrollment
15
Registered
2021-04-15
Start date
2021-04-08
Completion date
2021-06-30
Last updated
2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

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.

Interventions

BEHAVIORALRamadan 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

Sponsors

Bastyr University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in dopamine concentration0 to 30 daysPlasma dopamine level pg/mL
Change in serotonin concentration0 to 30 daysPlasma serotonin level ng/mL
Change in Brain-Derived Neurotrophic factor (BDNF) concentration0 to 30 daysPlasma BDNF level pg/mL
Change in Nerve Growth Factor (NGF) concentration0 to 30 daysPlasma NGF level pg/mL

Secondary

MeasureTime frameDescription
Change in mood measured by Positive And Negative Affect Scale (PANAS)0 to 30 daysPANAS questionnaire in English
Change in perceived stress level measured by Weekly Stress Inventory (WSI)0 to 30 daysWeekly Stress Inventory in English

Countries

United States

Contacts

Primary ContactMasa Sasagawa, ND, PhD
msasagawa@bastyr.edu425-602-3164
Backup ContactPaul Amieux, PhD
pamieux@bastyr.edu425-602-3132

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026