Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change from Baseline in BDNF levels at 4 weeks
研究概览
简要总结
This study investigates the effects of daily use of lithia water on blood tests of neuronal oxidative stress, mood, and well-being. Lithia water is a type of pure spring water containing trace levels of lithium, which is a naturally occurring mineral. Neuronal oxidative stress is caused by normal chemical reactions in the human body that sometimes result in damage to brain cells. Participation in this study will last for 8 weeks and includes daily use of study water for drinking.
The primary objective of this pilot study is to test the hypothesis that, in healthy male participants, daily use of lithia water will improve neurogenesis and antioxidant capacity as measured by serum levels of brain-derived neurotrophic factor (BDNF) and oxidative stress markers. Secondary objectives will include examining self-reported changes in mood, cognition, and well-being.
详细描述
There is some indication from epidemiological studies that areas with trace concentrations of lithium in drinking water have lower rates of suicide. This study will evaluate the effects of drinking EDJ (pronounced "edge") lithia spring water (which comes from a natural spring in the Rocky Mountains and contains trace amounts [0.68 mg/litre] of lithium) for 4 weeks, compared to drinking commercially available bottled water (which contains no lithium at all) for 4 weeks.
This pilot study has been designed as an 8-week randomized, counterbalanced, crossover study in 15 healthy male participants. Eligible participants will use lithia water or control water for daily ingestion for 4 weeks, then cross over to the other condition for another 4 weeks. At baseline and after each 4-week condition, participants will complete self-report questionnaires of mood, cognition and well-being, and blood samples will be assayed for BDNF and oxidative stress protein markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged 19-35 years. [Note: women are excluded in this pilot study because the variable effects of female sex hormones on oxidative stress markers and neurogenesis];
- •No current, past or family history (in first-degree relatives) of a major psychiatric disorder or alcohol/substance abuse/dependence;
- •Non-smokers [because smoking is associated with increased oxidative stress];
- •No active medical condition (e.g., thyroid disease);
- •No regular use of prescribed or over-the-counter medications or illicit substances;
- •Negative urine drug-screening test; and
- •Competency to give informed consent.
排除标准
- •See above
结局指标
主要结局
Change from Baseline in BDNF levels at 4 weeks
时间窗: Baseline, Wk 4, Wk 8
Blood samples will be assayed for brain-derived neurotrophic factor
次要结局
- Standardized, validated questionnaires querying mood and quality of life(Baseline, Wk 4, Wk 8)
- Standardized, validated questionnaires regarding cognitive functioning(Baseline, Wk 4, Wk 8)
- Change from Baseline in oxidative stress protein markers at 4 weeks(Baseline, Wk 4, Wk 8)