Oxidative Stress Clinical Trial
Official title:
Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
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