Effect of black seed on immunity in young healthy Saudi volunteers
Not Applicable
Completed
- Conditions
- Immunity of healthy individualsNot Applicable
- Registration Number
- ISRCTN14150499
- Lead Sponsor
- Imam Abdularahman bin Faisal University
- Brief Summary
2021 Results article in https://doi.org/10.12688/f1000research.73524.1 (added 14/03/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37901256/ (added 21/12/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 64
Inclusion Criteria
1. Healthy male IAU students
2. Age between 18 - 25 years
3. BMI 18.5 - 29.9 kg/m²
Exclusion Criteria
1. Students with any acute or chronic illness (unless acute illness occurred during the study)
2. Students with abnormalities in the basic laboratory investigations
3. Participants with less than 90% compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measured at baseline and 4 weeks:<br>1. Cytokines (IL-1, IL-4, IL-6, IL-10 and TNF) measured using ELISA<br>2. Immunoglobulins (IgG, IgM) measured using ELISA<br>3. Cellular immunity (CD4 & CD8) measured using flow cytometry
- Secondary Outcome Measures
Name Time Method Measured at baseline and 4 weeks:<br>1. Blood pressure measured using sphygmomanometer<br>2. Heart rate measured by the researcher<br>3. Liver function test measured using Alinity ci & hq machines (Abbot, USA)<br>4. Complete blood count measured using Alinity ci & hq machines (Abbot, USA)<br>5. Renal function test measured using Alinity ci & hq machines (Abbot, USA)<br>6. General health measured using a questionnaire