Natural Modulators of Immune Function and Mood

Completed · Not applicable · Has a placebo group

Conditions studied: Stress

In brief

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.

Key facts

Study ID

NCT05508529

Run by

3 Waves Wellness

People needed

120

Starts

2020-07-01

Expected to finish

2021-07-01

Last updated by the study team

2022-08-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and Females age 18 to 60 years
• Ability to complete strenuous off-road trail run, and planning to do so regardless of the study
• Willingness to consume the dietary supplements under investigation
• Willingness to undertake all protocol measurements and training regimens
• Ability to understand and sign the informed consent form (ICF)

You may not qualify if…

• Any supplements or medications that are stress/immune-suppressive or stress/immune-stimulant (e.g. herbal stimulants).
• Pregnant or lactating

Where it is running

• 3 Waves Wellness, LLC — Plymouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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