A study to compare the acute immune effects of a herbal blend compared to a placebo
- Conditions
- Immune cell activation, cell trafficking, and cytokine changes to pro- and anti-inflammatory cytokines, antiviral peptides, and restorative growth factorsNot Applicable
- Registration Number
- ISRCTN14647763
- Lead Sponsor
- nigen Inc.
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37699014/ (added 03/05/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1. Healthy adults
2. Age 18-75 years (inclusive)
3. BMI between 18.0 and 34.9 kg/m² (inclusive)
4. Veins easy to see in one or both arms (to allow for the multiple blood draws)
5. Willing to comply with study procedures, including:
5.1. Maintaining a consistent diet and lifestyle routine throughout the study
5.2. Consistent habit of bland breakfasts on days of clinic visits
5.3. Abstaining from exercise and nutritional supplements on the morning of a study visit
5.4. Abstaining from use of coffee, tea, and soft drinks for at least 1 hour prior to a clinic visit
5.5. Abstaining from music, candy, gum, computer/cell phone use, during clinic visits
1. Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
2. Taking anti-inflammatory medications on a daily basis
3. Currently experiencing intense stressful events/life changes
4. Currently in intensive athletic training (such as marathon runners)
5. Cancer during the past 12 months
6. Chemotherapy during the past 12 months
7. Currently treated with immune suppressant medication
8. Diagnosed with autoimmune disorders e.g. systemic lupus erythematosus, hemolytic anemia
9. Donation of blood during the study or within the 4 weeks prior to study start
10. Have received a cortisone shot within the past 12 weeks
11. Immunization during last month
12. Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication
13. Ongoing acute infections (including teeth, sinus, ear, etc)
14. Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change
15. An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying)
16. Unwilling to maintain a constant intake of supplements over the duration of the study
17. Anxiety about having blood drawn
18. Women of childbearing potential: pregnant, nursing, or trying to become pregnant
19. Known food allergies related to ingredients in the active test product or placebo
20. Prescription medication will be evaluated on a case-by-case basis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method