Golden Black Seed: Support of Metabolic Health and General Wellness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline cholesterol at 8 weeks.
研究概览
简要总结
To document effects of consuming Golden Black Seed (brand: New Chapter Inc.) on metabolic health and wellness in human subjects.
Golden Black Seed contains extracts from the turmeric root (Curcuma longa) and black cumin seeds (Nigella sativa). Both botanicals have been used traditionally in Asian cooking, and also in herbal medicine for reducing inflammation.
详细描述
For this clinical study, human participants will be tested over a period of 8 weeks. Below is a simplified diagram illustrating the involvement of each human subject, where all study participants will be tested on three different clinic days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult people of either gender;
- •Age 40-75 years (inclusive);
- •BMI 25-34.9 (inclusive);
排除标准
- •Cancer during past 12 months;
- •Chemotherapy during past 12 months;
- •Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery is allowed, including previous removal of appendix and gall bladder);
- •Currently consuming large doses of anti-inflammatory nutritional supplements, and unwilling to stop taking these supplements for 2 weeks prior to and during the study;
- •Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;
- •Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus, inflammatory bowel disease, Celiac disease);
- •Currently experiencing intense stressful events or life changes;
- •Currently in intensive athletic training (such as marathon runners);
- •Women of childbearing potential, who are pregnant, nursing, or trying to become pregnant;
- •Known food allergies or sensitivities related to the test products or placebo;
- •History of drug abuse during past two years;
- •Participation in another clinical trial involving a consumable test product.
研究组 & 干预措施
Golden Black Seed
Golden Black Seed, 1 capsule per day for 8 weeks.
干预措施: Golden Black Seed (Dietary Supplement)
结局指标
主要结局
Change from baseline cholesterol at 8 weeks.
时间窗: 8 weeks
Cholesterol levels will be measured at baseline and after 8 weeks.
次要结局
- Change from baseline lipid peroxidation at 8 weeks.(8 weeks)
- Change from baseline fasting glucose at 8 weeks.(8 weeks)
- Change from baseline Superoxide Dismutase at 8 weeks.(8 weeks)
- Change from baseline leptin at 8 weeks.(8 weeks)
- Change from baseline 8-OHdG marker for oxidative DNA damage at 8 weeks.(8 weeks)