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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01257867
• Other study ID #: H10-03015
• Status: Terminated
• Phase: N/A
• First received: December 8, 2010
• Last updated: November 7, 2012
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Dietary Supplement:
• Lithia water
Oral intake of approximately 2 litres (2L) daily for 4 weeks
• Natural spring water with negligible lithium levels
Oral intake of approximately 2 litres (2L) daily for 4 weeks

Locations

Country	Name	City	State
Canada	University of British Columbia, Department of Psychiatry	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Aquaceutica Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in BDNF levels at 4 weeks	Blood samples will be assayed for brain-derived neurotrophic factor	Baseline, Wk 4, Wk 8	No
Secondary	Standardized, validated questionnaires querying mood and quality of life		Baseline, Wk 4, Wk 8	No
Secondary	Standardized, validated questionnaires regarding cognitive functioning		Baseline, Wk 4, Wk 8	No
Secondary	Change from Baseline in oxidative stress protein markers at 4 weeks	Blood samples will be assayed for oxidative stress protein markers (superoxide dismutase, catalase, glutathione peroxidase, and TBARS)	Baseline, Wk 4, Wk 8	No

External Links

•   University of British Columbia