Biological and Psychological Health Effect of Ramadan Study

Quality of Life Clinical Trial

— HERS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846075
• Other study ID #: 21-1690
• Status: Recruiting
• Start date: April 8, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2021
• Source: Bastyr University
• Contact: Masa Sasagawa, ND, PhD
• Phone: 425-602-3164
• Email: msasagawa[@]bastyr.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 30, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

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

Locations

Country	Name	City	State
United States	Bastyr University	Kenmore	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bastyr University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dopamine concentration	Plasma dopamine level pg/mL	0 to 30 days
Primary	Change in serotonin concentration	Plasma serotonin level ng/mL	0 to 30 days
Primary	Change in Brain-Derived Neurotrophic factor (BDNF) concentration	Plasma BDNF level pg/mL	0 to 30 days
Primary	Change in Nerve Growth Factor (NGF) concentration	Plasma NGF level pg/mL	0 to 30 days
Secondary	Change in mood measured by Positive And Negative Affect Scale (PANAS)	PANAS questionnaire in English	0 to 30 days
Secondary	Change in perceived stress level measured by Weekly Stress Inventory (WSI)	Weekly Stress Inventory in English	0 to 30 days