Acute Effects of an Herbal Tea on Immune Surveillance and Activation.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.

Conditions
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Active Immune Response

Intervention / Treatment
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* Dietary Supplement: Herbal tea blend
* Dietary Supplement: Warm water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study uses a randomized double-blinded controlled cross-over study design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Herbal tea blend<br>1 cup of herbal tea blend containing Rosehip and other berry extracts. | Dietary Supplement: Herbal tea blend<br>* 1 cup of freshly brewed tea from an herbal tea blend.<br>|
| Sham Comparator: Warm water<br>1 cup of warm water. | Dietary Supplement: Warm water<br>* 1 cup of warm water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |