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临床试验/NCT06950424
NCT06950424进行中(未招募)不适用

Effect of Black Cumin Seed Oil on Cortisol, Stress and Quality of Life in Healthy Moderately-Stressed Adults

Shawn Talbott1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
cortisol

研究概览

简要总结

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).

详细描述

Black seed oil (BSO), derived from Nigella sativa, has been utilized in traditional medicine for centuries. Its active constituents, such as thymoquinone, nigellone, and other bioactive compounds, are associated with diverse pharmacological effects. Recent scientific investigations have confirmed its potential health benefits, particularly as a natural anti-inflammatory agent.

Historical records indicate the use of BSO as a spice and medicinal herb dating back at least 1,400 years. Traditional medicinal systems, including Unani, Islamic, and Ayurvedic medicine, recognize its wide-ranging therapeutic properties. Traditional uses of black seed oil include remedies for respiratory ailments, digestive disorders, and skin conditions. However, contemporary scientific investigations have provided more precise evidence of its effects on biochemical pathways involved in inflammation, cellular protection, energy metabolism, and stress responses.

Nigella sativa seeds are rich in various bioactive compounds, including:

  • Thymoquinone (TQ): The most studied bioactive constituent with diverse pharmacological activities, including anti-inflammatory, antioxidant, antibacterial, and anticancer effects.
  • Terpenes and Terpenoids: p-cymene, carvacrol, thymohydroquinone (THQ), dihydrothymoquinone (DHTQ), α-thujene, thymol, t-anethole, β-pinene, α-pinene, and γ-terpinene.
  • Fatty Acids: Predominantly linoleic acid, oleic acid, and palmitic acid.
  • Phytosterols: Notably, β-sitosterol and stigmasterol.
  • Alkaloids: Including nigellicimine, nigellidine, and nigellamines.
  • Polyphenols: Such as quercitrin and kaempferol.

Because of the diversity of bioactive compounds found in BSO, its historical usage as a "cure-all" across various traditional medicine systems, and our emerging understanding of its clinical utility against modern stress-related ailments, this study explores black seed oil's therapeutic potential and relevance to modern health challenges, particularly cortisol modulation and stress response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Placebo

Placebo Comparator

maltodextrin placebo

干预措施: black cumin seed oil (Dietary Supplement)

Supplement

Experimental

500mg black cumin seed oil

干预措施: black cumin seed oil (Dietary Supplement)

结局指标

主要结局

cortisol

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

measures of salivary cortisol

次要结局

  • mood state(from baseline to week 8, with interim measures at week 1 and week 4)

研究者

发起方
Shawn Talbott
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Shawn Talbott

PI

3 Waves Wellness

研究点 (1)

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