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

NCT04491461 | Completed

• 1 other identifier: 152-018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Immune Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change to natural killer cell activation status

  Changes at 1 and 2 hours after consumption

Study Arms (2)

Herbal tea blend

ACTIVE COMPARATOR

1 cup of herbal tea blend containing Rosehip and other berry extracts.

Dietary Supplement: Herbal tea blend

Warm water

SHAM COMPARATOR

1 cup of warm water.

Dietary Supplement: Warm water

Interventions

Herbal tea blend DIETARY_SUPPLEMENT

1 cup of freshly brewed tea from an herbal tea blend.

Herbal tea blend

Warm water DIETARY_SUPPLEMENT

1 cup of warm water

Warm water

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

Gitte Jensen

Klamath Falls, Oregon, 97601-5904, United States

Location

Study Officials

• GITTE JENSEN

  NIS Labs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study uses a randomized double-blinded controlled cross-over study design.

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 29, 2020
• Study Start: July 27, 2020
• Primary Completion: October 25, 2021
• Study Completion: December 19, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)