NCT06660004已完成不适用
The Effects of 8-Week Creatine HCl and Creatine Ethyl Ester Supplementation on Cognitive Performance, Multidimensional Fatigue, Brain Metabolism, and Biochemical Indices in Perimenopausal and Menopausal Women
University of Novi Sad, Faculty of Sport and Physical Education2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine HCl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and menopausal women
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index 18.5 - 29.9 kg/m2
- •Free of major chronic diseases or acute disorders (including AD and dementia (MMSE score > 25 points)
- •MENOPAUSAL: no menstrual cycle for consecutive 12 months (with no other obvious causes)
- •PERIMENOPAUSAL: Still menstruating (regular or irregular) but have at least one of the following symptoms: (1) hot flashes, (2) sleep disturbances, (3) mood swings, and (4) concentration difficulties
- •Given written informed consent
排除标准
- •History of dietary supplement use 4 weeks before the study commences
- •Pregnancy (or planning pregnancy)
- •Abnormal values for lab clinical chemistry (> 2 SD)
- •Unwillingness to return for follow-up analysis
- •Participation in other clinical trials
结局指标
主要结局
Fatigue
时间窗: Change from baseline fatigue at 8 weeks
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
次要结局
- Time to exhaustion(Change from baseline time to exhaustion at 8 weeks)
- Brain creatine(Change from baseline brain creatine concentrations at 8 weeks)
- Cognitive interference(Change from baseline fatigue at 8 weeks)
- Amyloid b(Change from baseline time to exhaustion at 8 weeks)
研究者
Sergej Ostojic
Professor, Head of the Applied Bioenergetics Lab
University of Novi Sad, Faculty of Sport and Physical Education
研究点 (2)
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