ImmuneNCT05566314
Beverage for Immune Support
A study testing Amunizer in people with Immune, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
Evaluate the effects of a beverage supplement on immune health over an 8 week intervention using either a placebo or active supplement. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune
- What is being tested?
- Amunizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 31 Mar 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Health Research Center
Franklin, Tennessee, 37067
About this study
Official title: Amunizer for Immune Support: A Randomized, Placebo Controlled, Double Blind Clinical Trial
Evaluate the effects of a beverage supplement on immune health over an 8 week intervention using either a placebo or active supplement.
- Conditions
- Immune
- Being tested
- Amunizer, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmunizerDietary supplement
12 oz. herbal, probiotic and antioxidant herbal beverage
PlaceboOther
12 oz. flavored beverage
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Herbal and probiotic beverage Receives: Dietary Supplement: Amunizer |
| Placebo | Placebo comparator | Similar beverage without the probiotics and botanicals Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with symptoms documented by the Franklin Health Immune Inventory (FHII)
The FHII measures incidence and severity of over 50 signs of immune health. Days with symptoms will range from 0 to 56 days, indicating no sickness to sick every day.
Measured: from baseline to the end of the study, 8 weeks
Severity of symptoms documented by the FHII
The FHII measures incidence and severity of over 50 signs of immune health. Symptom severity is measured on a likert scale with higher scores indicating greater symptom severity.
Measured: from baseline to the end of the study, 8 weeks
Secondary outcomes (6)
Incidence and severity on the upper respiratory symptom subscale of the FHII
The FHII subscale measures 16 respiratory symptoms on a likert scale with higher scores indicating greater severity.
Measured: from baseline to the end of the study, 8 weeks
Incidence and severity on the gastrointestinal symptom subscale of the FHII
The FHII subscale measures 11 gastrointestinal symptoms on a likert scale with higher scores indicating greater severity.
Measured: from baseline to the end of the study, 8 weeks
Incidence and severity on the dermal symptom subscale of the FHII
The FHII subscale measures 9 dermal symptoms on a likert scale with higher scores indicating greater severity.
Measured: from baseline to the end of the study, 8 weeks
Change from baseline scores on the Franklin Energy Level Inventory
The Franklin Energy Level Inventory measures signs of energy across 6 subdomains, with higher scores indicating greater levels of energy.
Measured: 8 week
Change from baseline scores on the Franklin Sleep Quality Inventory
The Franklin Sleep Quality Inventory measures sleep quality across 7 subdomains, with higher scores indicating higher quality sleep.
Measured: 8 week
Change from baseline scores on the Franklin Mood Scale
The Franklin Mood Scale measures mood stats across 4 subdomains, with higher scores indicating improvements to mood.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start22 Sep 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmuneStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessie Hawkins, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566314
- Sponsor's protocol ID
- 22-06-3600
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amunizer for Immune Support: A Randomized, Placebo Controlled, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05566314
- Acronym / sponsor ID
- 22-06-3600
- Conditions
- Immune
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
Evaluate the effects of a beverage supplement on immune health over an 8 week intervention using either a placebo or active supplement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: AmunizerHerbal and probiotic beverage |
| Placebo | Placebo comparator | Other: PlaceboSimilar beverage without the probiotics and botanicals |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Amunizer12 oz. herbal, probiotic and antioxidant herbal beverage | Dietary supplement | Intervention |
| Placebo12 oz. flavored beverage | Other | Placebo |
Primary outcome
Number of days with symptoms documented by the Franklin Health Immune Inventory (FHII)
Time frame: from baseline to the end of the study, 8 weeks
The FHII measures incidence and severity of over 50 signs of immune health. Days with symptoms will range from 0 to 56 days, indicating no sickness to sick every day.
Severity of symptoms documented by the FHII
Time frame: from baseline to the end of the study, 8 weeks
The FHII measures incidence and severity of over 50 signs of immune health. Symptom severity is measured on a likert scale with higher scores indicating greater symptom severity.
6 secondary outcomes
Incidence and severity on the upper respiratory symptom subscale of the FHII
Time frame: from baseline to the end of the study, 8 weeks
Incidence and severity on the gastrointestinal symptom subscale of the FHII
Time frame: from baseline to the end of the study, 8 weeks
Incidence and severity on the dermal symptom subscale of the FHII
Time frame: from baseline to the end of the study, 8 weeks
Change from baseline scores on the Franklin Energy Level Inventory
Time frame: 8 week
Change from baseline scores on the Franklin Sleep Quality Inventory
Time frame: 8 week
Change from baseline scores on the Franklin Mood Scale
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amunizer in people with Immune, run by Nutraceuticals Research Institute 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 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?
Results are not available in the source record.
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?
Number of days with symptoms documented by the Franklin Health Immune Inventory (FHII) (time frame: from baseline to the end of the study, 8 weeks). The study lists 2 primary outcomes in all. 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 4 Oct 2022.