Beverage for Immune Support

September 30, 2022 updated by: Jessie Hawkins, Franklin Health Research

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Franklin Health Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Herbal and probiotic beverage
Dietary supplement: Amunizer
12 oz. herbal, probiotic and antioxidant herbal beverage
PLACEBO_COMPARATOR: Placebo
Similar beverage without the probiotics and botanicals
Other: Placebo
12 oz. flavored beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to the end of the study, 8 weeks
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.
from baseline to the end of the study, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity on the upper respiratory symptom subscale of the FHII
Time Frame: from baseline to the end of the study, 8 weeks
The FHII subscale measures 16 respiratory symptoms on a likert scale with higher scores indicating greater severity.
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
The FHII subscale measures 11 gastrointestinal symptoms on a likert scale with higher scores indicating greater severity.
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
The FHII subscale measures 9 dermal symptoms on a likert scale with higher scores indicating greater severity.
from baseline to the end of the study, 8 weeks
Change from baseline scores on the Franklin Energy Level Inventory
Time Frame: 8 week
The Franklin Energy Level Inventory measures signs of energy across 6 subdomains, with higher scores indicating greater levels of energy.
8 week
Change from baseline scores on the Franklin Sleep Quality Inventory
Time Frame: 8 week
The Franklin Sleep Quality Inventory measures sleep quality across 7 subdomains, with higher scores indicating higher quality sleep.
8 week
Change from baseline scores on the Franklin Mood Scale
Time Frame: 8 week
The Franklin Mood Scale measures mood stats across 4 subdomains, with higher scores indicating improvements to mood.
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franklin Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 22, 2022

Primary Completion (ANTICIPATED)

January 31, 2023

Study Completion (ANTICIPATED)

March 31, 2023

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (ACTUAL)

October 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 22-06-3600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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