Clinical Proof-of-concept Study on Rapid Immune Modulating Effects

Clinical Poof-of-concept Study on Rapid Immune Modulating Effects

Clinical-proof-of concept study, comparing the acute immune impacts of of 2 doses of a novel blend of supplements to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 2 different doses of the blend at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the blend on immune function as compared to the placebo.

Study Overview

• Status: Recruiting
• Conditions: Immune Surveillance
• Intervention / Treatment: Dietary supplement: Transfer factor from colostrum ultrafiltrate

Detailed Description

Clinical-proof-of-concept study comparing the acute immune effects of 2 doses of a nutraceutical blend, and a placebo. The nutraceutical blend is based on a transfer factor isolated from cow colostrum ultrafiltrate.

24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be taking placebo, dose 1, and dose 2, each separated by a 1-week washout period.

Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 24 hours following administration. At each blood sample collection, 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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • Recruiting
      • NIS Labs
      • Contact: Gitte Jensen; Phone Number: 5418840112; Email: gitte@nislabs.com
      • Contact: Alex Cruickshank; Phone Number: 541-884-0112; Email: alex@nislabs.com
      • Principal Investigator: Gitte Jensen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults
• Veins easy to see in one or both arms
• Willing to comply with study procedures, including
• Maintaining a consistent diet and lifestyle routine throughout the study;
• Consistent habit of bland breakfast on days of clinic visits
• Abstaining from exercising on 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;
• Abstaining from music, candy, gum, computer/cell phone use, during clinic visits

Exclusion Criteria:

• Previous major gastrointestinal surgery
• Taking anti-inflammatory medications on a daily basis
• Currently experiencing intense stressful events/life changes
• Currently in intensive athletic training (such as marathon runner)
• Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
• An unusual sleep routine
• 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 sensitivities related to ingredients in active test product placebo Prescription medication evaluated on a cas-by-case basis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where he/she will consume the active intervention.	Dietary supplement: Transfer factor from colostrum ultrafiltrate; Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.
Experimental: Group B; Crossover study: Participants will be consuming the active intervention on a clinic day at least 1 week prior to a clinic day where he/she will consume placebo.	Dietary supplement: Transfer factor from colostrum ultrafiltrate; Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune Surveillance and Alertness	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune responsiveness	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

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 058-006

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