Recruiting

Observational Study

Sponsor:

Bastyr University

Code:

NCT04846075

Conditions

Quality of Life

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Ramadan fasting, praying, and welfare for poor

Study Details

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.

Conditions

Quality of Life

Study ID

NCT04846075

Start date

Apr 8, 2021

Status verified date

Apr, 2021

Completion date

Jun 30, 2021

Anticipated

Primary completion date

May 15, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Ramadan Group

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

Interventions

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

Primary outcome measure

  • Change in dopamine concentration [ Time Frame: 0 to 30 days ]
  • Change in serotonin concentration [ Time Frame: 0 to 30 days ]
  • Change in Brain-Derived Neurotrophic factor (BDNF) concentration [ Time Frame: 0 to 30 days ]
  • Change in Nerve Growth Factor (NGF) concentration [ Time Frame: 0 to 30 days ]

Central Contacts and Locations

Central contacts

Masa Sasagawa, ND, PhD

425-602-3164msasagawa@bastyr.edu

Paul Amieux, PhD

425-602-3132pamieux@bastyr.edu

Locations

Bastyr University

Recruiting

Kenmore, Washington, United States, 98028

Contacts

Masa Sasagawa, ND, PhD

425-602-3164msasagawa@bastyr.edu

More Information

Sponsor

Bastyr University

Last update posted

Apr 15, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bastyr University on 2021-04-15.