NCT03619265已完成不适用
Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness. A Randomized, Double-blind, Placebo-controlled Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain level
研究概览
简要总结
The purpose for this protocol is to perform a double-blind, randomized, placebo-controlled, parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical product on physical and mental energy levels and overall wellness.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults of either gender;
- •35-75 years old;
- •Chronic joint/muscle related pain for at least past 6 months;
- •Body mass index (BMI) at or below 34.9 kg/m2.
排除标准
- •Bariatric surgery;
- •Diagnosed with diabetes Type I;
- •Taking medication for diabetes Type II;
- •Known serious chronic health condition;
- •Serious active illness within past 12 months;
- •Major surgery within the past 3 months;
- •Major trauma within the past 3 months;
- •Alcohol consumption of more than four standard units/day (for example more than four regular 12 oz beers (5% alcohol), four small 5-oz glasses of wine (12% alcohol), or four 1.5 oz shots of 80-proof spirits), or more than 28 units per week;
- •Daily consumption of Nopalea or similar juice products during the past month;
- •Currently taking anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
- •Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable);
- •Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;
- •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;
- •Any other condition or observation that the investigator judges may adversely affect the person's ability to complete the study;
- •Women of child-bearing potential: Pregnant, breast-feeding, or trying to become pregnant;
- •Known allergies to ingredients in the test and placebo products.
结局指标
主要结局
Pain level
时间窗: Baseline, 2 weeks, and 8 weeks.
Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
次要结局
- Range of motion(Baseline and 8 weeks.)
研究者
研究点 (2)
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