ClinicalTrials.gg
Status unknownNCT04846075HERSUpdated Apr 15, 2021

Biological and Psychological Health Effect of Ramadan Study

An observational study in Quality of Life, sponsored by Bastyr University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-15.

Sponsored by Bastyr University · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Quality of Life
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In context

Lead sponsor

Bastyr University is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Ramadan Group

    Diurnal fasting and spiritual practices. Operationally assessed by the level of compliance to Sawm, Salat, and Zakat.

    Behavioral: Ramadan fasting, praying, and welfare for poor

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

    Also known as: Diurnal fasting or Sawm; five or more prayers or Salat; donation or volunteering or Zakat

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What researchers measure

Primary outcomes

  1. Change in dopamine concentration

    Plasma dopamine level pg/mL

    Time frame: 0 to 30 days

  2. Change in serotonin concentration

    Plasma serotonin level ng/mL

    Time frame: 0 to 30 days

  3. Change in Brain-Derived Neurotrophic factor (BDNF) concentration

    Plasma BDNF level pg/mL

    Time frame: 0 to 30 days

  4. Change in Nerve Growth Factor (NGF) concentration

    Plasma NGF level pg/mL

    Time frame: 0 to 30 days

Secondary outcomes

  1. Change in mood measured by Positive And Negative Affect Scale (PANAS)

    PANAS questionnaire in English

    Time frame: 0 to 30 days

  2. Change in perceived stress level measured by Weekly Stress Inventory (WSI)

    Weekly Stress Inventory in English

    Time frame: 0 to 30 days

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Study locations

1 of 1 sites recruiting
  • Bastyr University
    Kenmore, Washington 98028, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No — Data are collected by subject IDs (SIDs). Only aggregate results will be available

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2021 (actual). Primary completion is estimated for May 2021, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2021
First posted
Apr 15, 2021
StartActual
Apr 8, 2021
Primary completionEst.
May 15, 2021
CompletionEst.
Jun 30, 2021
Last update
Apr 15, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04846075
Lead sponsor
Bastyr University
Responsible party
Masa Sasagawa, ND, PhD (Assistant Research Scientist, Bastyr University) — Principal investigator
First posted
Apr 15, 2021
Start date
Apr 8, 2021
Primary completion
May 15, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Apr 15, 2021

Study contacts

Masa Sasagawa, ND, PhD
Contact
msasagawa@bastyr.edu
425-602-3164
Paul Amieux, PhD
Contact
pamieux@bastyr.edu
425-602-3132
Masa Sasagawa, ND, PhD
principal investigator · Bastyr University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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