Active Immune Response
Conditions
Brief summary
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.
Detailed description
A randomized, cross-over, controlled study design will be used to evaluate the effects of consumption of 1 cup of an herbal tea blend to consumption of the same volume of warm water. The study is of 3 weeks' duration, with evaluation of the herbal tea blend versus warm water at week 1 and week 2 with a one week washout between visits. On each visit, a baseline blood draw is performed, followed by consuming of the herbal tea blend or warm water. Blood draws are performed at 1 and 2 hours after consumption.
Interventions
DIETARY_SUPPLEMENTHerbal tea blend
1 cup of freshly brewed tea from an herbal tea blend.
DIETARY_SUPPLEMENTWarm water
1 cup of warm water
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The study uses a randomized double-blinded controlled cross-over study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change to natural killer cell numbers in blood circulation | Changes at 1 and 2 hours after consumption | Flow cytometry evaluation of natural killer cell numbers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change to natural killer cell activation status | Changes at 1 and 2 hours after consumption | Flow cytometry evaluation of CD69 expression on natural killer cells in the blood circulation |
Countries
United States
Outcome results
None listed