NCT05566314

Brief Summary

Evaluate the effects of a beverage supplement on immune health over an 8 week intervention using either a placebo or active supplement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

September 30, 2022

Last Update Submit

September 30, 2022

Conditions

Immune

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    from baseline to the end of the study, 8 weeks

  • Incidence and severity on the gastrointestinal symptom subscale of the FHII

    from baseline to the end of the study, 8 weeks

  • Incidence and severity on the dermal symptom subscale of the FHII

    from baseline to the end of the study, 8 weeks

  • Change from baseline scores on the Franklin Energy Level Inventory

    8 week

  • Change from baseline scores on the Franklin Sleep Quality Inventory

    8 week

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Herbal and probiotic beverage

Dietary Supplement: Amunizer

Placebo

PLACEBO COMPARATOR

Similar beverage without the probiotics and botanicals

Other: Placebo

Interventions

AmunizerDIETARY_SUPPLEMENT

12 oz. herbal, probiotic and antioxidant herbal beverage

Intervention
PlaceboOTHER

12 oz. flavored beverage

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 4, 2022

Study Start

September 22, 2022

Primary Completion

January 31, 2023

Study Completion

March 31, 2023

Last Updated

October 4, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)