Clinical trial NCT01257867: Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants
Official title: Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oxidative Stress
Keywords: Brain-derived neurotrophic factor
Oxidative stress
Neurogenesis
Lithium
Lithia water
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Aquaceutica Group
First posted: 2010-12-10
Enrollment: 5
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* See above

Primary outcomes:
measure: Change from Baseline in BDNF levels at 4 weeks
timeFrame: Baseline, Wk 4, Wk 8
Secondary outcomes:
measure: Standardized, validated questionnaires querying mood and quality of life
timeFrame: Baseline, Wk 4, Wk 8
measure: Standardized, validated questionnaires regarding cognitive functioning
timeFrame: Baseline, Wk 4, Wk 8
measure: Change from Baseline in oxidative stress protein markers at 4 weeks
timeFrame: Baseline, Wk 4, Wk 8
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia, Department of Psychiatry
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Raymond W Lam, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: