NCT01598272已完成4 期
A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single-Center Study on the Effects of a Proprietary Blend of Herbal Extract Supplement on Cellular Detoxification, Inflammation, and Cumulative Cognitive Index as Well as Gene Expression in Middle-Aged Adult Women.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pharmanex
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Determine effects of investigational supplement on gene expression profiles.
研究概览
简要总结
Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles
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
- 35 Years 至 73 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 35-73 years
- •Signed informed consent
- •BMI between 23 and 35 kg/m2
- •A resting normotensive blood pressure is defined as a systolic blood pressure between 90-145 mmHg and a diastolic blood pressure of 50 90 mmHg
- •BioPhotonic scanner score below 30,000
- •Use of effective method of contraception by females of childbearing [potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study]. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; or any double barrier method. Women who have had a hysterectomy or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal for at least 1 year prior to Visit 1 are not considered to be of childbearing potential.
- •Ability to speak and understand English.
- •Willing to consume one high-fat high carbohydrate meal at the last visit consisting of 1 McDonald's egg Mcmuffin with cheese (no meat), 1 Sausage McMuffin with cheese (no egg), 2 hashbrowns, 1 12 oz Coke Cola or Sprite.
- •Willing to not exercise the morning of your last visit
排除标准
- •Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue)
- •Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study.
- •Antihypertensive medication use.
- •Allergies to any ingredients contained in the Investigational Product.
- •Consumption of more than 600 mg of caffeine from all sources per day (equivalent to 24 oz. caffeinated coffee, 96 oz. of soda, 60 oz. of tea, 60 oz. energy drinks , or a combination thereof).
- •Consumption of herbal supplement known to affect energy levels (e.g., ginseng, cordyceps, licorice, Lycium, pomegranate, etc.).
- •Consumption of any of the supplements included in the formulas (Cordyceps sinensis, Panax Ginseng extract, pomegranate extract, red orange complex, grape seed extract or broccoli seed extract).
- •Known iron deficiency anemia.
- •Treatment for insomnia or depression within 30-days prior to the screening visit.
- •Recently started taking medication known to effect energy (e.g., thyroid medication). If taking medication (e.g., thyroid medication), must be stable for at least four months.
- •Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit.
- •Planned surgical procedure during the course of the study.
- •Currently participating in another study or have done so within 30 days prior to the screening visit or is likely to enroll in another clinical or nutritional study.
- •Any laboratory value that the investigator deems clinically significant.
- •Currently participating in a weight loss program or planning to go on a weight loss diet during the course of the study.
- •Allergies to egg or dairy products, Vegetarian or unwilling to consuming sausage.
结局指标
主要结局
Determine effects of investigational supplement on gene expression profiles.
时间窗: Day 0, Day 28, Day 56
Gene Expression Panel (microarray PBMCs), Inflammatory Panel, Oxidative stress Markers-including glutathione panel and F2 isoprostane, Anti-oxidant panel, and Lipid Panel
次要结局
- Determine effects of investigational supplement on markers of inflammation(Day 0, Day 28, Day 56)
- Determine effects of investigational supplement on composite cognitive index(Day 0, Day 28, Day 56)
- Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)(Day 0, Day 28, Day 56)
- Determine changes in Quality of Life(Day 0, Day 28, Day 56)
- Determine changes in sleep patterns and quality(Day 0, Day 28, Day 56)
- Determine changes to overall health(Day 0, Day 28, Day 56)
- Establish a safety profile of investigational supplement(Day 0, Day 28, Day 56)
- Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)(Day 0, Day 28, Day 56)
- Determine changes in Biophotonic Scanner Scores(Day 0, Day 28, Day 56)
- Determine changes in skin advanced glycation endproducts (AGE) levels(Day 0, Day 28, Day 56)
研究者
研究点 (2)
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