Active — Not RecruitingNot Applicable

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

United States40 participantsStarted 2025-04-01

Plain-language 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).

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cortisol

Timeframe: from baseline until week 8, with interim measures at week 1 and week 4

Trial details

NCT IDNCT06950424

SponsorShawn Talbott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-01

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