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

Sponsor
Natural Immune Systems Inc (Other)
Overall Status
Recruiting
CT.gov ID
NCT04491461
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
16.8
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Herbal tea blend
  • Dietary Supplement: Warm water
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The study uses a randomized double-blinded controlled cross-over study design.The study uses a randomized double-blinded controlled cross-over study design.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.
Actual Study Start Date :
Jul 27, 2020
Anticipated Primary Completion Date :
Oct 25, 2021
Anticipated Study Completion Date :
Dec 19, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gitte Jensen Klamath Falls Oregon United States 97601-5904

Sponsors and Collaborators

  • Natural Immune Systems Inc

Investigators

  • Study Director: GITTE JENSEN, NIS Labs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Natural Immune Systems Inc
ClinicalTrials.gov Identifier:
NCT04491461
Other Study ID Numbers:
  • 152-018
First Posted:
Jul 29, 2020
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 1, 2021