Anthocyanin-rich Extracts for Cancer

Overseen By Alex Cruickshank

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Natural Immune Systems Inc

Must not be taking: Anti-inflammatories, Anxiolytics, Hypnotics, Antidepressants

Disqualifiers: Major gastrointestinal surgery, Intense stress, Intensive athletic training, Unusual sleep routine, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-75 who have visible veins for blood draws. Participants must skip exercise and supplements on the morning of a visit, avoid caffeine an hour before, maintain a consistent diet and lifestyle, eat bland breakfasts on clinic days, and refrain from music, candy, gum, or device use during visits.

Inclusion Criteria

I am a healthy adult.

I can avoid exercise and supplements on the morning of my study visit.

I avoid coffee, tea, and soft drinks for at least an hour before clinic visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume a test product on each of the four clinic days, with a 1-week wash-out period between each product

5 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in stem cell numbers in blood circulation

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anthocyanin-rich berry extract
• Anthocyanin-rich flower/leaf extract
• Berry/leaf blend

Trial Overview

The study is testing the immediate immune effects of three nutraceutical ingredients: anthocyanin-rich berry extract, flower/leaf extract, and their blend compared to a placebo. The goal is to understand how these natural substances affect stem cell surveillance in the body.

How Is the Trial Designed?

Group I: Crossover Group 4, randomized Experimental Treatment 4 Interventions

Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C.

Group II: Crossover Group 3, randomized Experimental Treatment 4 Interventions

Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B.

Group III: Crossover Group 2, randomized Experimental Treatment 4 Interventions

Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A.

Group IV: Crossover Group 1, randomized Experimental Treatment 4 Interventions

Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D.

Who Is Running the Clinical Trial?

Natural Immune Systems Inc

Lead Sponsor

Trials

20

Recruited

510+