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

N

Natural Immune Systems

Status

Completed

Conditions

Active Immune Response

Treatments

Dietary Supplement: Herbal tea blend
Dietary Supplement: Warm water

Study type

Interventional

Funder types

Other

Identifiers

NCT04491461
152-018

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Herbal tea blend
Active Comparator group
Description:
1 cup of herbal tea blend containing Rosehip and other berry extracts.
Treatment:
Dietary Supplement: Herbal tea blend
Warm water
Sham Comparator group
Description:
1 cup of warm water.
Treatment:
Dietary Supplement: Warm water

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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