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

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.

Study Overview

• Status: Terminated
• Conditions: Oxidative Stress
• Intervention / Treatment: Dietary supplement: Lithia water; Dietary supplement: Natural spring water with negligible lithium levels

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2A1
      • University of British Columbia, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: EDJ lithia spring water; (previous) Ilumati lithia spring water
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in BDNF levels at 4 weeks	Blood samples will be assayed for brain-derived neurotrophic factor	Baseline, Wk 4, Wk 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized, validated questionnaires querying mood and quality of life		Baseline, Wk 4, Wk 8
Standardized, validated questionnaires regarding cognitive functioning		Baseline, Wk 4, Wk 8
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Aquaceutica Group
• Investigators: Principal Investigator: Raymond W Lam, MD, FRCPC, University of British Columbia

Publications and helpful links

Helpful Links

• University of British Columbia

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 8, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (Estimate): December 10, 2010

Study Record Updates

• Last Update Posted (Estimate): November 9, 2012
• Last Update Submitted That Met QC Criteria: November 7, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Oxidative stress; Neurogenesis; Lithium; Brain-derived neurotrophic factor; Lithia water
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: H10-03015