Clinical Proof-of-concept Study on Immune Surveillance and Alertness

August 3, 2023 updated by: Natural Immune Systems Inc

Clinical proof-of-concept study comparing the acute. effects of an algae-based dietary supplement on immune surveillance and alertness. This study involves twenty-four participants composed of healthy adults, who will be taking either a placebo or supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the supplement on immune function compared to a placebo.

Long term effects and lingering effects will be tested using the same parameters, following a consumption period of one week, as well as a washout period of one week.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Clinical-proof-of-concept study comparing the acute immune effects as well as the lasting and lingering effects of a dietary supplement, and a placebo. The dietary supplement is composed of whole Euglena gracilis algae, produced using a proprietary fermentation technique.

24 subjects will participate in a placebo-controlled, double-blinded, cross-over study design, wherein they will be taking placebo, or dietary supplement each separated by a 1-week washout period to evaluate rapid effects. Following which the subjects will also be taking placebo or dietary supplement continuously for 1 week each, to evaluate the long term and lingering effects.

For acute evaluation, blood samples are taken 1 hour after participants arrive, the dose is then administered. Samples are take 1 hour and 2 hours following administration. For long-term and lingering evaluation, blood samples are taken 1 hour after participants arrive. At all blood sample collections, a spit sample will also be taken for salivary IgA testing.

A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles. Ex vivo immune challenges and salivary IgA testing will be used to determine the direct impacts on immune cells.

Study Type

Interventional

Enrollment (Estimated)

24

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
    • Oregon
      • Klamath Falls, Oregon, United States, 97601
        • Recruiting
        • NIS Labs
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gitte Jensen, PhD

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults
  • Veins easy to see in both arms
  • Willing to comply with a 24-hours wash-out period for vitamins and nutritional supplements
  • Willing to comply with study procedures, including maintaining a consistent diet and lifestyle routine throughout the study. Consistent habit of bland breakfasts on days of clinic visits, abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit, abstaining from use of coffee, tea, and soft-drinks for at least one hour prior to a clinic visit
  • Willing to abstain from music, candy, gum, computer/cellphone use during clinic visits

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 (81 mg aspirin is acceptable)
  • Vaccination during past 2 weeks
  • 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
  • An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights)
  • Unwilling to maintain a constant intake of supplements over the duration of the study
  • Anxiety about having blood drawn
  • People of childbearing potential: Pregnant, nursing, or trying to become pregnant
  • Known food allergies or sensitivities related to the test product or placebo
  • Prescription medication will be evaluated on a case-by-case basis

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group A
Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where they will consume the active intervention. Following the second clinic day, the participant will consume active intervention for 7 days. The participant will then undergo a washout period of 7 days.
Dietary supplement: Whole Algae
Whole Euglena gracilis algae, produced by proprietary fermentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Surveillance and Alerness
Time Frame: 2 hours, 1 week
Observation of changes in immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following administration.
2 hours, 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune communication
Time Frame: 2 hours, 1 week
Observation of changes in serum cytokine levels
2 hours, 1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Responsiveness
Time Frame: 2 hours, 1 week
Ex vivo immune challenges, observing the capabilities of anti-bacterial and anti-viral defenses. Additionally, mucosal immune protection as determined by salivary IgA, defensins, and transferrin changes .
2 hours, 1 week

Collaborators and Investigators

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

Sponsor

Natural Immune Systems Inc

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)

July 12, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 153-012

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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