Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental and Cognitive Function and Improved Mitochondrial Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in fatigue level from baseline
研究概览
简要总结
The purpose for this protocol is to perform an open-label human clinical pilot study on the effects of consumption of two nutraceutical blends in subjects with long-term unexplained fatigue interfering with daily living.
详细描述
This is an open-label human clinical study to evaluate the effects of consumption of the nutraceutical product ATP-Fuel, compared to the nutraceutical product ATP-II. The study participants will be randomized to one of three groups: consuming ATP-Fuel (5 capsules, twice daily); consuming ATP-II (3 capsules, once daily); or consuming ATP-II (3 capsules, twice daily). The study is of 8 weeks' duration, with evaluation at baseline, 1, 4, and 8 weeks of product consumption.
At each visit the following measurements and procedures are performed: Blood pressure, questionnaires pertaining to fatigue, pain and wellness, and a blood draw. The blood is used for testing of lipid peroxidation and mitochondrial volume and metabolic activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 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 18-75 years (inclusive);
- •BMI between 18.0 and 34.9 (inclusive);
- •Experiencing fatigue, at a level that moderately to severely interferes with daily activities, for the past 6 months.
排除标准
- •Cancer during past 12 months;
- •Chemotherapy during past 12 months;
- •Currently taking blood thinning medication (81mg aspirin allowed);
- •Getting regular joint injections (such as cortisone shots);
- •Have received a cortisone shot within past 12 weeks;
- •Major surgery within the past 3 months;
- •Major trauma within the past 3 months;
- •Any other significant disease or disorder that the investigator judges may put the subject at risk because of participation in the study, or may influence the result of the study;
- •Known food allergies or sensitivities related to the test products;
- •Participation in another research study involving an investigational product in the past month;
- •Planned surgery within 2 weeks of completing the study;
- •Previous major surgery to stomach or intestines [(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal];
- •Unwilling to maintain a constant intake of supplements over the duration of the study;
- •Women who are pregnant, nursing, or trying to become pregnant.
结局指标
主要结局
Change in fatigue level from baseline
时间窗: 8 weeks
Piper Fatigue Scale - Change from baseline will be evaluated. Each question scores 0-10, 22 questions.
次要结局
- Change in primary and secondary pain levels from baseline(8 weeks)