40 Participants Needed

Black Cumin Seed Oil for Stress

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

Yes, if you are currently using anti-inflammatory or antidepressant medications or supplements, you will need to stop taking them at least 4 weeks before the study and during the study.

How does black cumin seed oil differ from other stress treatments?

Black cumin seed oil, particularly rich in thymoquinone, is unique because it not only helps reduce stress but also improves sleep and boosts immunity, which are interconnected factors. Unlike many stress treatments, it works by modulating neurotransmitters like serotonin and reducing inflammation, offering a multi-targeted approach without significant side effects.12345

What data supports the effectiveness of the treatment Black Cumin Seed Oil for stress?

Research shows that black cumin seed oil, particularly its component thymoquinone, may help reduce anxiety and stress-related neurological disorders by affecting brain chemicals and reducing inflammation. In animal studies, it has been shown to produce anti-anxiety effects and protect brain cells from damage.12567

Who Is on the Research Team?

ST

Shawn Talbott, PhD

Principal Investigator

3 Waves Wellness

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-70 who feel moderately stressed. They must be willing to take black cumin seed oil supplements for 8 weeks and not be on certain medications or supplements, especially anti-inflammatory or antidepressants taken in the last month. People with autoimmune diseases or those who are pregnant cannot participate.

Inclusion Criteria

I am between 18 and 70 years old and generally healthy but feel moderately stressed.
I am either female or male.
Informed consent
See 1 more

Exclusion Criteria

Inability to complete prescribed supplement regimen
Pregnancy
I haven't taken any anti-inflammatory or antidepressant medications or supplements in the last 4 weeks.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline measurements are collected before the start of treatment

1 week
1 visit (in-person)

Treatment

Participants receive either 500mg black cumin seed oil or placebo daily

8 weeks
3 visits (in-person) at weeks 1, 4, and 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Black Cumin Seed Oil
Trial Overview The study tests if black cumin seed oil can help manage stress by looking at changes in saliva cortisol levels and mood states like tension, irritability, focus, fatigue, vigor, and overall well-being over an 8-week period.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SupplementExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shawn Talbott

Lead Sponsor

Citations

Repeated administration of Nigella sativa decreases 5-HT turnover and produces anxiolytic effects in rats. [2017]
Clinical and experimental effects of Nigella sativa and its constituents on respiratory and allergic disorders. [2022]
Evaluation of the protective effect of Nigella sativa extract and its primary active component thymoquinone against DMBA-induced breast cancer in female rats. [2020]
Thymoquinone-rich black cumin oil attenuates ibotenic acid-induced excitotoxicity through glutamate receptors in Wistar rats. [2023]
A proprietary black cumin oil extract (Nigella sativa) (BlaQmax®) modulates stress-sleep-immunity axis safely: Randomized double-blind placebo-controlled study. [2023]
Safety assessment of black cumin fixed and essential oil in normal Sprague Dawley rats: Serological and hematological indices. [2022]
A phase I clinical trial to evaluate the safety of thymoquinone-rich black cumin oil (BlaQmax®) on healthy subjects: Randomized, double-blinded, placebo-controlled prospective study. [2022]
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