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NCT05508529 · ClinicalTrials.gov registry record · NA

Natural Modulators of Immune Function and Mood

A NA study of Stress, sponsored by 3 Waves Wellness.

Completed
Registry status
NA
Development phase
120
Enrollment target
1
Study location

NCT05508529 is a NA study of Stress that has completed, run by 3 Waves Wellness. The registered enrollment target is 120 participants, below the 785-participant average among 152 other Stress trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05508529, a NA study of Stress, has completed, sponsored by 3 Waves Wellness.

COMPLETED
Registry status
NA
Development phase
120 participants
Enrollment target
1
Study location

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

What the Registry Record Tells You About NCT05508529

The ClinicalTrials.gov registry entry for NCT05508529 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 785-participant average among 152 other Stress trials with a reported enrollment target (85% lower). The listed sponsor is 3 Waves Wellness, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT05508529 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

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.

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).

Who is sponsoring clinical trial NCT05508529?

This trial is sponsored by 3 Waves Wellness, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

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