Biological and Psychological Health Effect of Ramadan Study

NCT04846075 | Unknown

• 1 other identifier: 21-1690
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

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

  0 to 30 days

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

  0 to 30 days

Study Arms (1)

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

Ramadan fasting, praying, and welfare for poor BEHAVIORAL

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

Ramadan Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bastyr University: lead

Study Sites (1)

Bastyr University

Kenmore, Washington, 98028, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

10 mL serum (SST) and 10 mL (plasma) EDTA

MeSH Terms

Interventions

phosphoribosylanthranilate isomerase; Social Work; Poverty

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Masa Sasagawa, ND, PhD

  Bastyr University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Masa Sasagawa, ND, PhD

CONTACT

425-602-3164; msasagawa@bastyr.edu

Paul Amieux, PhD

CONTACT

425-602-3132; pamieux@bastyr.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 15, 2021
• Study Start: April 8, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 30, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)