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

Natural Immune Systems

Status: Enrolling

Conditions: Immune Surveillance

Treatments: Dietary Supplement: Transfer factor from colostrum ultrafiltrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05364710

058-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

24 participants in 2 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Transfer factor from colostrum ultrafiltrate

Group B

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Transfer factor from colostrum ultrafiltrate