Quality of LifeHERSNCT04846075
Biological and Psychological Health Effect of Ramadan Study
An observational study of Quality of Life, run by Bastyr University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Ramadan fasting, praying, and welfare for poor
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bastyr University
Kenmore, Washington, 98028
Masa Sasagawa, ND, PhD, 425-602-3164, msasagawa@bastyr.edu
About this study
Official title: 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.
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.
- Conditions
- Quality of Life
- Being tested
- Ramadan fasting, praying, and welfare for poor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramadan fasting, praying, and welfare for poorBehavioural
Also called Diurnal fasting or Sawm; five or more prayers or Salat; donation or volunteering or Zakat
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
| Study group | Role | What they receive |
|---|---|---|
| Ramadan Group | Diurnal fasting and spiritual practices. Operationally assessed by the level of compliance to Sawm, Salat, and Zakat. Receives: Behavioral: Ramadan fasting, praying, and welfare for poor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dopamine concentration
Plasma dopamine level pg/mL
Measured: 0 to 30 days
Change in serotonin concentration
Plasma serotonin level ng/mL
Measured: 0 to 30 days
Change in Brain-Derived Neurotrophic factor (BDNF) concentration
Plasma BDNF level pg/mL
Measured: 0 to 30 days
Change in Nerve Growth Factor (NGF) concentration
Plasma NGF level pg/mL
Measured: 0 to 30 days
Secondary outcomes (2)
Change in mood measured by Positive And Negative Affect Scale (PANAS)
PANAS questionnaire in English
Measured: 0 to 30 days
Change in perceived stress level measured by Weekly Stress Inventory (WSI)
Weekly Stress Inventory in English
Measured: 0 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start8 Apr 2021
- Primary completion15 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masa Sasagawa, ND, PhD, Bastyr University
- Investigators
- Masa Sasagawa, ND, PhD, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846075
- Sponsor's protocol ID
- 21-1690
- Acronym
- HERS
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are collected by subject IDs (SIDs). Only aggregate results will be available
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ramadan on the Blood Concentration of Serotonin, Dopamine, Brain-Derived Neurotorophic Factor and Nerve Growth Factor: A Replication Study
- ClinicalTrials.gov ID
- NCT04846075
- Acronym / sponsor ID
- HERS / 21-1690
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramadan Group | – | Behavioral: Ramadan fasting, praying, and welfare for poorDiurnal fasting and spiritual practices. Operationally assessed by the level of compliance to Sawm, Salat, and Zakat. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramadan fasting, praying, and welfare for poorAlso: Diurnal fasting or Sawm; five or more prayers or Salat; donation or volunteering or ZakatAbstaining 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 | Behavioural | Ramadan Group |
Primary outcome
Change in dopamine concentration
Time frame: 0 to 30 days
Plasma dopamine level pg/mL
Change in serotonin concentration
Time frame: 0 to 30 days
Plasma serotonin level ng/mL
Change in Brain-Derived Neurotrophic factor (BDNF) concentration
Time frame: 0 to 30 days
Plasma BDNF level pg/mL
Change in Nerve Growth Factor (NGF) concentration
Time frame: 0 to 30 days
Plasma NGF level pg/mL
2 secondary outcomes
Change in mood measured by Positive And Negative Affect Scale (PANAS)
Time frame: 0 to 30 days
Change in perceived stress level measured by Weekly Stress Inventory (WSI)
Time frame: 0 to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: No. Data are collected by subject IDs (SIDs). Only aggregate results will be available
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masa Sasagawa, ND, PhD principal investigator
Bastyr University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Bastyr University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masa Sasagawa, ND, PhD (425-602-3164, msasagawa@bastyr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dopamine concentration (time frame: 0 to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.