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

Active Immune Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491461
• Other study ID #: 152-018
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: December 19, 2021

Study information

• Verified date: June 2022
• Source: Natural Immune Systems Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Active Immune Response

Intervention

Dietary Supplement:
• Herbal tea blend
1 cup of freshly brewed tea from an herbal tea blend.
• Warm water
1 cup of warm water

Locations

Country	Name	City	State
United States	Gitte Jensen	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

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