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

NCT ID: NCT01257867

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Oxidative Stress

Keywords

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Brain-derived neurotrophic factor Oxidative stress Neurogenesis Lithium Lithia water

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lithia spring water

Lithia water (active) for 4 weeks then placebo water for 4 weeks

Group Type EXPERIMENTAL

Lithia water

Intervention Type DIETARY_SUPPLEMENT

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

Natural spring water

Placebo water for 4 weeks then lithia water (active) for 4 weeks

Group Type PLACEBO_COMPARATOR

Natural spring water with negligible lithium levels

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Lithia water

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

Intervention Type DIETARY_SUPPLEMENT

Natural spring water with negligible lithium levels

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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EDJ lithia spring water (previous) Ilumati lithia spring water

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aquaceutica Group

UNKNOWN

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond W Lam, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Related Links

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http://www.ubc.ca

University of British Columbia

Other Identifiers

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H10-03015

Identifier Type: -

Identifier Source: org_study_id