Biological and Psychological Health Effect of Ramadan Study (HERS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life
• Intervention / Treatment: Behavioral: Ramadan fasting, praying, and welfare for poor

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.

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Masa Sasagawa, ND, PhD; Phone Number: 425-602-3164; Email: msasagawa@bastyr.edu
• Study Contact Backup: Name: Paul Amieux, PhD; Phone Number: 425-602-3132; Email: pamieux@bastyr.edu

Study Locations

• United States
  • Washington
    • Kenmore, Washington, United States, 98028
      • Recruiting
      • Bastyr University
      • Contact: Masa Sasagawa, ND, PhD; Phone Number: 425-602-3164; Email: msasagawa@bastyr.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 Names: Diurnal fasting or Sawm; five or more prayers or Salat; donation or volunteering or Zakat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dopamine concentration	Plasma dopamine level pg/mL	0 to 30 days
Change in serotonin concentration	Plasma serotonin level ng/mL	0 to 30 days
Change in Brain-Derived Neurotrophic factor (BDNF) concentration	Plasma BDNF level pg/mL	0 to 30 days
Change in Nerve Growth Factor (NGF) concentration	Plasma NGF level pg/mL	0 to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mood measured by Positive And Negative Affect Scale (PANAS)	PANAS questionnaire in English	0 to 30 days
Change in perceived stress level measured by Weekly Stress Inventory (WSI)	Weekly Stress Inventory in English	0 to 30 days

Collaborators and Investigators

• Sponsor: Bastyr University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Anticipated): May 15, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 21-1690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data are collected by subject IDs (SIDs). Only aggregate results will be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No