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

NCT05364710 | Unknown

• 1 other identifier: 058-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Immune communication

  Observation of changes in serum cytokine levels

  2 hours

Secondary Outcomes (1)

• Immune Surveillance and Alertness

  2 hours

Other Outcomes (1)

• Immune responsiveness

  2 hours

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

Transfer factor from colostrum ultrafiltrate DIETARY_SUPPLEMENT

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will not be informed on which intervention they receive on any given day.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, double-blinded, cross-over study design.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: May 7, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)