Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Oxidative Stress |
Dietary Supplement: Lithia water Dietary Supplement: Natural spring water with negligible lithium levels |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants |
- Change from Baseline in BDNF levels at 4 weeks [ Time Frame: Baseline, Wk 4, Wk 8 ] [ Designated as safety issue: No ]Blood samples will be assayed for brain-derived neurotrophic factor
- Standardized, validated questionnaires querying mood and quality of life [ Time Frame: Baseline, Wk 4, Wk 8 ] [ Designated as safety issue: No ]
- Standardized, validated questionnaires regarding cognitive functioning [ Time Frame: Baseline, Wk 4, Wk 8 ] [ Designated as safety issue: No ]
- Change from Baseline in oxidative stress protein markers at 4 weeks [ Time Frame: Baseline, Wk 4, Wk 8 ] [ Designated as safety issue: No ]Blood samples will be assayed for oxidative stress protein markers (superoxide dismutase, catalase, glutathione peroxidase, and TBARS)
| Enrollment: | 5 |
| Study Start Date: | March 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lithia spring water
Lithia water (active) for 4 weeks then placebo water for 4 weeks
|
Dietary Supplement: Lithia water
Oral intake of approximately 2 litres (2L) daily for 4 weeks
Other Names:
|
|
Placebo Comparator: Natural spring water
Placebo water for 4 weeks then lithia water (active) for 4 weeks
|
Dietary Supplement: Natural spring water with negligible lithium levels
Oral intake of approximately 2 litres (2L) daily for 4 weeks
|
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| Ages Eligible for Study: | 19 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts 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
Contacts and Locations| Canada, British Columbia | |
| University of British Columbia, Department of Psychiatry | |
| Vancouver, British Columbia, Canada, V6T 2A1 | |
| Principal Investigator: | Raymond W Lam, MD, FRCPC | University of British Columbia |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01257867 History of Changes |
| Other Study ID Numbers: | H10-03015 |
| Study First Received: | December 8, 2010 |
| Last Updated: | November 7, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Brain-derived neurotrophic factor Oxidative stress Neurogenesis Lithium Lithia water |
Additional relevant MeSH terms:
|
Lithium Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents |
ClinicalTrials.gov processed this record on May 19, 2013