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COMPLETED NA

Natural Modulators of Immune Function and Mood

NCT05508529 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this proposal is to recruit 20 healthy subjects per ingredient arm (5 arms x 20 subjects; N= 120 total) to participate in a research study investigating the effects of dietary supplementation for one-month with different dietary supplement formulations (versus placebo; N=20) that may have benefits for supporting respiratory health, psychological stress, and quality of life. Supplements to be studied (all are commercially available): 1. Chaga (mushroom extract) 2. Arava (algae concentrate) 3. Thymoquin (black cumin seed oil) 4. Thymoquin + Astaxanthin (antioxidant carotenoid) 5. Thymoquin + Omega 3 (fish oil) 6. Placebo (corn starch) In order to "stress" volunteers, participants will train for and complete a strenuous off-road trail marathon to induce both physical and mental stress.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Chaga Mushroom
  • DIETARY_SUPPLEMENT Algae Extract
  • DIETARY_SUPPLEMENT Black Cumin Seed Oil
  • DIETARY_SUPPLEMENT Black Cumin Seed Oil + Astaxanthin
  • DIETARY_SUPPLEMENT Black Cumin Seed Oil + Omega 3

Study Locations (1)

Massachusetts

  • 3 Waves Wellness, LLC — Plymouth

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2020-07-01
Est. Completion 2021-07-01
Phase NA

Sponsor

3 Waves Wellness

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05508529

The ClinicalTrials.gov registry entry for NCT05508529 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is 3 Waves Wellness, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Stress appearing as the primary indexed condition, and to 5 interventions — of which Chaga Mushroom is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05508529 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05508529 about?

NCT05508529 is a clinical study titled "Natural Modulators of Immune Function and Mood". The objective of this proposal is to recruit 20 healthy subjects per ingredient arm (5 arms x 20 subjects; N= 120 total) to participate in a research study investigating the effects of dietary supplementation for one-month with different dietary supplement formulations (versus placebo; N=20) that ma...

What is the current status of trial NCT05508529?

This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2020-07-01. Estimated completion is 2021-07-01.

What conditions does trial NCT05508529 study?

This clinical trial studies the following conditions: Stress. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05508529?

The interventions under investigation include: Chaga Mushroom (DIETARY_SUPPLEMENT), Algae Extract (DIETARY_SUPPLEMENT), Black Cumin Seed Oil (DIETARY_SUPPLEMENT), Black Cumin Seed Oil + Astaxanthin (DIETARY_SUPPLEMENT), Black Cumin Seed Oil + Omega 3 (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05508529?

This trial is sponsored by 3 Waves Wellness, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05508529 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial