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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Immune Surveillance

In brief

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.

Key facts

Study ID

NCT05364710

Run by

Natural Immune Systems Inc

People needed

24

Starts

2022-05-07

Expected to finish

2023-06-01

Last updated by the study team

2022-05-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• NIS Labs — Klamath Falls, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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