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Completed

NCT Number: NCT04491461

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gitte Jensen

Klamath Falls, Oregon, 97601-5904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Herbal tea blend

Dietary Supplement

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

Warm water

Dietary Supplement

1 cup of warm water

Primary outcomes

  1. Change to natural killer cell numbers in blood circulation

    Time frame: Changes at 1 and 2 hours after consumption

    Flow cytometry evaluation of natural killer cell numbers

Secondary outcomes

  1. Change to natural killer cell activation status

    Time frame: Changes at 1 and 2 hours after consumption

    Flow cytometry evaluation of CD69 expression on natural killer cells in the blood circulation

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2020
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.