Last reviewed · How we verify
NCT05508529
Natural Modulators of Immune Function and Mood
NA trial testing Chaga Mushroom in Stress in 120 participants. Completed in 1 July 2021.
1 March 2021
Quick facts
| Lead sponsor | 3 Waves Wellness |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 1 July 2020 |
| Primary completion | 1 March 2021 |
| Estimated completion | 1 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Chaga Mushroom
- Algae Extract
- Black Cumin Seed Oil
- Black Cumin Seed Oil + Astaxanthin
- Black Cumin Seed Oil + Omega 3
- Placebo
Conditions studied
- Stress — all drugs for Stress →
Sponsor
3 Waves Wellness
Who can join
Adults 18 to 70, any sex, with Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05508529
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other 3 Waves Wellness trials
Trials by the same sponsor.
- NCT06808061 — Effects of Lactobacillus Plantarum KABP-51 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adul · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05508529 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by 3 Waves Wellness
- Last refreshed: 19 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05508529.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing