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Natural Modulators of Immune Function and Mood

NCT05508529 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-19

No results posted yet for this 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

  • Stress

Interventions

DIETARY_SUPPLEMENT

Chaga Mushroom

Effect of chaga on immune/mood support

DIETARY_SUPPLEMENT

Algae Extract

Effect of algae extract on immune/mood support

DIETARY_SUPPLEMENT

Black Cumin Seed Oil

Effect of black cumin seed oil on immune/mood support

DIETARY_SUPPLEMENT

Black Cumin Seed Oil + Astaxanthin

Effect of Black Cumin Seed Oil + Astaxanthin blend on immune/mood support

DIETARY_SUPPLEMENT

Black Cumin Seed Oil + Omega 3

Effect of Black Cumin Seed Oil + Omega3 blend on immune/mood support

DIETARY_SUPPLEMENT

Placebo

Placebo control

Sponsors & Collaborators

  • 3 Waves Wellness

    lead INDUSTRY

Principal Investigators

  • Shawn Talbott, PhD · 3 Waves Wellness

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-03-01
Completion
2021-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508529 on ClinicalTrials.gov