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

Not Applicable

Completed

• Conditions: Active Immune Response

• Registration Number: NCT04491461
• Lead Sponsor: Natural Immune Systems Inc

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.

Study Timeline

• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-26
• Study Start: 2020-07-27
• Study First Posted: 2020-07-29
• Primary Completion: 2021-10-25
• Study Completion: 2021-12-19
• Status Verified: 2022-06
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gitte Jensen; 🇺🇸 Klamath Falls, Oregon, United States