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

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

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.

Study Overview

• Status: Completed
• Conditions: Active Immune Response
• Intervention / Treatment: Dietary supplement: Herbal tea blend; Dietary supplement: Warm water

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601-5904
      • Gitte Jensen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Herbal tea blend; 1 cup of herbal tea blend containing Rosehip and other berry extracts.	Dietary supplement: Herbal tea blend; 1 cup of freshly brewed tea from an herbal tea blend.
SHAM_COMPARATOR: Warm water; 1 cup of warm water.	Dietary supplement: Warm water; 1 cup of warm water

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2020
• Primary Completion (ACTUAL): October 25, 2021
• Study Completion (ACTUAL): December 19, 2021

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 152-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No