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Clinical Trials in the USA / NCT06950424
Active, not recruiting Not applicable

Effect of Black Cumin Seed Oil Supplementation on Cortisol, Stress and Mood

NCT06950424 · tracked via the Priya Life Science USA tracker
Sponsor
Shawn Talbott
Phase
Not applicable
Started
2025-04-01
Last updated
2025-04-30

Condition(s) studied

StressMood

Investigational drug(s) / intervention(s)

black cumin seed oil

black cumin seed oil: 500mg of black cumin seed oil standardized for 3% thymoquinone)

Study summary

The primary objective of this study will be to collect data to support the role of black cumin seed oil, also known as black seed oil (BSO), in moderating the stress response, including objective markers of stress (cortisol/DHEA) as well as subjective measures (mood/stress/sleep/beauty). The primary outcomes will be salivary cortisol, subjective stress, and psychological vigor.

Subjects will be recruited from among the clients of the Certified Mental Wellness Coaches (CMWCs) that have passed the digital badge course via Marietta College (https://www.credly.com/org/marietta-college/badge/certified-mental-wellness-coach-cmwc-online).

If volunteers meet the inclusion/exclusion criteria, they will review/sign the Informed Consent Form (ICF - attached) before any Baseline measurements are collected.

Because BSO is already known to deliver a wide range of potential health benefits, including anti-inflammatory, anti-oxidant, anti-diabetic, and immune-modulating effects - we expect to observe improvements on both subjective psychological and objective biochemical measures. Our primary outcome measures will be salivary cortisol and psychological mood state (POMS, including tension, mood, irritability, focus, fatigue, vigor and well-being).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * • Healthy moderately-stressed adults; Female and Male / Age 18-70 * Informed consent * Ability/desire to participate in 8-week supplement program Exclusion Criteria: * Inability to complete prescribed supplement regimen * Current use of incompatible medications or supplements, including anti-inflammatory or antidepressant medications and supplements in the last 4 weeks before the study and during the study * Auto-immune or inflammatory disease diagnosis * Pregnancy

Primary outcome measure(s)

  • cortisol — from baseline until week 8, with interim measures at week 1 and week 4
    measures of salivary cortisol

Trial sites (1)

FacilityCityRegionStatus
3 Waves Wellness Plymouth Massachusetts

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06950424 on ClinicalTrials.gov ↗ ← All trials in the USA