Active Immune ResponseNCT04491461
Acute Effects of an Herbal Tea on Immune Surveillance and Activation.
A study testing Herbal tea blend and Warm water in people with Active Immune Response, run by Natural Immune Systems Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Active Immune Response
- What is being tested?
- Herbal tea blend and Warm water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 19 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.
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.
Read the 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.
- Conditions
- Active Immune Response
- Being tested
- Herbal tea blend, Warm water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal tea blendDietary supplement
1 cup of freshly brewed tea from an herbal tea blend.
Warm waterDietary supplement
1 cup of warm water
| Study group | Role | What they receive |
|---|---|---|
| Herbal tea blend | Active comparator | 1 cup of herbal tea blend containing Rosehip and other berry extracts. Receives: Dietary Supplement: Herbal tea blend |
| Warm water | Sham comparator | 1 cup of warm water. Receives: Dietary Supplement: Warm water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change to natural killer cell numbers in blood circulation
Flow cytometry evaluation of natural killer cell numbers
Measured: Changes at 1 and 2 hours after consumption
Secondary outcomes (1)
Change to natural killer cell activation status
Flow cytometry evaluation of CD69 expression on natural killer cells in the blood circulation
Measured: Changes at 1 and 2 hours after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start27 Jul 2020
- Primary completion25 Oct 2021
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Immune ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study uses a randomized double-blinded controlled cross-over study design.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GITTE JENSEN, Study director, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491461
- Sponsor's protocol ID
- 152-018
- Status last verified
- Jun 2022
- First submitted
- 26 Jul 2020
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.
- ClinicalTrials.gov ID
- NCT04491461
- Acronym / sponsor ID
- 152-018
- Conditions
- Active Immune Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study uses a randomized double-blinded controlled cross-over study design.
| Arm | Type | Receives |
|---|---|---|
| Herbal tea blend | Active comparator | Dietary Supplement: Herbal tea blend1 cup of herbal tea blend containing Rosehip and other berry extracts. |
| Warm water | Sham comparator | Dietary Supplement: Warm water1 cup of warm water. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal tea blend1 cup of freshly brewed tea from an herbal tea blend. | Dietary supplement | Herbal tea blend |
| Warm water1 cup of warm water | Dietary supplement | Warm water |
Primary outcome
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
1 secondary outcome
Change to natural killer cell activation status
Time frame: Changes at 1 and 2 hours after consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GITTE JENSEN study director
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal tea blend and Warm water in people with Active Immune Response, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change to natural killer cell numbers in blood circulation (time frame: Changes at 1 and 2 hours after consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.