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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2021-12-19

Brief Summary

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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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Detailed Description

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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.

Conditions

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Active Immune Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Herbal tea blend

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

Group Type ACTIVE_COMPARATOR

Herbal tea blend

Intervention Type DIETARY_SUPPLEMENT

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

Warm water

1 cup of warm water.

Group Type SHAM_COMPARATOR

Warm water

Intervention Type DIETARY_SUPPLEMENT

1 cup of warm water

Interventions

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Herbal tea blend

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

Intervention Type DIETARY_SUPPLEMENT

Warm water

1 cup of warm water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes