Active Immune Response Clinical Trial
Official title:
Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.
NCT number | NCT04491461 |
Other study ID # | 152-018 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 27, 2020 |
Est. completion date | December 19, 2021 |
Verified date | June 2022 |
Source | Natural Immune Systems Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A small cross-over trial on 24 people involving an herbal tea blend to test whether consuming 1 cup of tea triggers changes in the numbers of natural killer cells in the blood circulation as evidence of immune cell trafficking within 2 hours.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 19, 2021 |
Est. primary completion date | October 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Healthy adults; - Age 18-75 years (inclusive); - Veins easy to see in both arms (to allow for the multiple blood draws); - Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements; Exclusion Criteria: - Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder); - Taking anti-inflammatory medications on a daily basis; - Currently experiencing intense stressful events/ life changes; - Currently in intensive athletic training (such as marathon runners); - Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel; - Actively depressed; - An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying); - Unwilling to maintain a constant intake of supplements over the duration of the study; - Anxiety about having blood drawn; - Women of childbearing potential: Pregnant, nursing, or trying to become pregnant; - Known food allergies related to ingredients in active test product. |
Country | Name | City | State |
---|---|---|---|
United States | Gitte Jensen | Klamath Falls | Oregon |
Lead Sponsor | Collaborator |
---|---|
Natural Immune Systems Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change to natural killer cell numbers in blood circulation | Flow cytometry evaluation of natural killer cell numbers | Changes at 1 and 2 hours after consumption | |
Secondary | Change to natural killer cell activation status | Flow cytometry evaluation of CD69 expression on natural killer cells in the blood circulation | Changes at 1 and 2 hours after consumption |