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

NCT06950424 | Active Not Recruiting

• 1 other identifier: BlackSeedCortisol2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Stress; Mood

Keywords

stress; mood

Outcome Measures

Primary Outcomes (1)

• cortisol

  measures of salivary cortisol

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

Secondary Outcomes (1)

• mood state

  from baseline to week 8, with interim measures at week 1 and week 4

Study Arms (2)

Supplement

EXPERIMENTAL

500mg black cumin seed oil

Dietary Supplement: black cumin seed oil

Placebo

PLACEBO COMPARATOR

maltodextrin placebo

Dietary Supplement: black cumin seed oil

Interventions

black cumin seed oil DIETARY_SUPPLEMENT

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

Placebo; Supplement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy moderately-stressed adults; Female and Male / Age 18-70
• Informed consent
• Ability/desire to participate in 8-week supplement program

You may not qualify if:

• 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

Sponsors & Collaborators

• Shawn Talbott: lead

Study Sites (1)

3 Waves Wellness

Plymouth, Massachusetts, 02360, United States

Location

MeSH Terms

Interventions

Nigella sativa oil

Study Officials

• Shawn Talbott, PhD

  3 Waves Wellness

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Model Details: Two arms - active supplement and placebo

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 30, 2025
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)