Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Pharmacokinetics

In brief

A trial on acute antioxidant protection and immune effects when 24 people consume a novel nutraceutical blend compared to a placebo on different test days.

Key facts

Study ID

NCT05042674

Run by

Natural Immune Systems Inc

People needed

24

Starts

2021-09-20

Expected to finish

2023-05-05

Last updated by the study team

2022-06-09

Who can join

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

You may qualify if…

• Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements
• Willing to maintain a consistent diet and lifestyle routine throughout the study
• Willing to avoid consumption of meals where the predominant ingredients include mushrooms, seafood, and organ meat (liver, heart).*
• Willing to abstaining from exercising on the morning of a study visit
• Willing to abstain from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit
• Willing to abstain from music, candy, gum, computer/cell phone use, during clinic visits.

You may not qualify if…

• Previous major gastrointestinal surgery
• Active chronic immunological disease
• Currently taking daily OTC medications, prescription pain medications, antipsychotic medications, anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects if the test product, nutritional supplements containing medicinal mushroom extracts
• Diagnose with Type I diabetes, autoimmune disorders
• Getting regular joint injections
• Active severe chronic disease (such as HIV, chronic hepatitis)
• Currently experiencing intense stressful events/ life changes
• Currently in intensive athletic training
• Experiencing an unusual sleep routine
• Unwilling to maintain a constant intake of supplements over the duration of the study
• Anxiety about having blood drawn
• Women who are pregnant, nursing, or trying to become pregnant
• Known food allergies to ingredients in test product

Where it is running

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

Full record on ClinicalTrials.gov

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