NCT04263246已完成不适用
Does Medium-Term Supplementation With PhytoDyNAmic Affect Exercise Performance and Antioxidant Status in Healthy Men and Women: A Randomized Controlled Trial?
University of Novi Sad, Faculty of Sport and Physical Education1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年9月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in time to exhaustion
研究概览
简要总结
We evaluated here the effects of 6-week intervention with herbal supplement on exercise performance outcomes and serum biomarkers of antioxidant status. In addition, we also assessed the long-term effects (6-month) of the intervention in elderly adults.
详细描述
Experimental protocol
- Double-blind, randomized, placebo-controlled cross-over trial
- 6-week intervention trial (with additiional follow-up arm after 6 months)
- Experimental intervention (PhytoDyNAmic) = 6 capsules per day
- Placebo (inulin) = 1 g per day b.i.d.
- Administration = 3 capsules with breakfast and 3 capsules with dinner
- Wash-out period = 2 weeks
- No changes in physical activity patterns and diet during the study
Outcomes assessed at baseline and at each follow-up:
- Exercise performance during incremental running-to-exhaustion test
- Serum biomarkers of antioxidant status
- Total antioxidant capacity (TAC)
- Superoxide dismutase (SOD)
- Telomerase activity
Early termination criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Body mass index 19 - 25 kg/m2
- •Free of major chronic diseases or acute disorders
排除标准
- •Use of dietary supplements within 4 weeks before study commences
- •Unwillingness to return for follow-up analysis
研究组 & 干预措施
PhytoDyNAmic
Experimental
Six capsules per day b.i.d.
干预措施: PhytoDyNAmic (Dietary Supplement)
Inulin
Placebo Comparator
Six capsules per day b.i.d.
干预措施: Inulin (Dietary Supplement)
结局指标
主要结局
Change in time to exhaustion
时间窗: Baseline vs. 6 weeks post-intervention
Baseline vs. 6 weeks
次要结局
- Change in serum superoxide dismutase(Baseline vs. 6 weeks post-intervention)
- Change in serum telomerase activity(Baseline vs. 6 weeks post-intervention)
- Change in serum total antioxidant capacity(Baseline vs. 6 weeks post-intervention)
研究者
Sergej Ostojic
Professor
University of Novi Sad, Faculty of Sport and Physical Education
研究点 (1)
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