NCT06640465已完成2 期
A Randomized, Placebo-Controlled Trial Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations
OvationLab12 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Plasma Coenzyme Q10
研究概览
简要总结
The primary purpose of this study is to compare the safety and effectiveness of commercially available dietary supplements believed to increase coenzyme Q10 (CoQ10) concentrations.
An 8-week, randomized, placebo-controlled clinical trial will be conducted comparing the effectiveness of four commercially available dietary supplements on increasing CoQ10 concentrations and self-reported health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males or females age ≥ 40 years
- •Ability to read and speak English
排除标准
- •Daily use within the past 2 months of any dietary supplements containing CoQ10 or geranylgeraniol (GG)
- •Taking a statin medication within the past 6 months
- •Current daily usage of H2 blockers or PPI medications
- •Current daily use of bisphosphonates
- •Current daily tobacco smoker
- •Known allergies to any substance in the study products
- •Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
- •Current diagnosis of a chronic health condition (e.g., cancer, Crohn's disease) deemed clinically contraindicated for the study protocol.
- •Participant in a clinical trial in the previous 30 days.
- •Participants unable to provide consent
研究组 & 干预措施
Ubiquinone (NOW CoQ10 200mg)
Experimental
干预措施: Ubiquinone (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Geranylgeraniol (Annatto-GG™ 300)
Experimental
干预措施: Geranylgeraniol (Dietary Supplement)
Ubiquinol + geranylgeraniol combination (Designs for Health - CoQnol™ 200)
Experimental
干预措施: Ubiquinol + geranylgeraniol (Dietary Supplement)
Ubiquinol (Jarrow Formulas QH-absorb® 200 mg)
Experimental
干预措施: Ubiquinol (Dietary Supplement)
结局指标
主要结局
Plasma Coenzyme Q10
时间窗: Baseline and 8 weeks
次要结局
- Comprehensive metabolic panel(Baseline and 8 weeks)
- Lipid panel(Baseline and 8 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health(Baseline and 8 weeks)
- Profile of Mood States - Vigor Subscale(Baseline and 8 weeks)
- Short Form 36 (SF-36) - Vitality Subscale(Baseline and 8 weeks)
研究者
研究点 (12)
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