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Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants

Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01257867
Enrollment
5
Registered
2010-12-10
Start date
2011-03-31
Completion date
2012-10-31
Last updated
2012-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

Brain-derived neurotrophic factor, Oxidative stress, Neurogenesis, Lithium, Lithia water

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.

Interventions

DIETARY_SUPPLEMENTLithia water

Oral intake of approximately 2 litres (2L) daily for 4 weeks

DIETARY_SUPPLEMENTNatural spring water with negligible lithium levels

Oral intake of approximately 2 litres (2L) daily for 4 weeks

Sponsors

Aquaceutica Group
CollaboratorUNKNOWN
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
19 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in BDNF levels at 4 weeksBaseline, Wk 4, Wk 8Blood samples will be assayed for brain-derived neurotrophic factor

Secondary

MeasureTime frameDescription
Standardized, validated questionnaires querying mood and quality of lifeBaseline, Wk 4, Wk 8
Standardized, validated questionnaires regarding cognitive functioningBaseline, Wk 4, Wk 8
Change from Baseline in oxidative stress protein markers at 4 weeksBaseline, Wk 4, Wk 8Blood samples will be assayed for oxidative stress protein markers (superoxide dismutase, catalase, glutathione peroxidase, and TBARS)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026