Recruiting

Immune Modulation

Sponsor:

Natural Immune Systems Inc

Code:

NCT05364710

Conditions

Immune Surveillance

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Transfer factor from colostrum ultrafiltrate

Study Details

Brief summary:

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.

Conditions

Immune Surveillance

Study ID

NCT05364710

Start date

May 7, 2022

Status verified date

May, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Transfer factor from colostrum ultrafiltrate

Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.

Primary outcome measure

  • Immune communication [ Time Frame: 2 hours ]

Central Contacts and Locations

Locations

NIS Labs

Recruiting

Klamath Falls, Oregon, United States, 97601

Contacts

Alex Cruickshank

541-884-0112alex@nislabs.com

Gitte Jensen

5418840112gitte@nislabs.com

Principal Investigator:

Gitte Jensen

More Information

Sponsor

Natural Immune Systems Inc

Last update posted

May 13, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Natural Immune Systems Inc on 2022-05-13.