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

• ClinicalTrials.gov Identifier: NCT01257867
• Recruitment Status: Terminated
• First Posted: December 10, 2010
• Last Update Posted: November 9, 2012
• Sponsor: University of British Columbia
• Collaborator: Aquaceutica Group
• Information provided by (Responsible Party): University of British Columbia

Tracking Information

• First Submitted Date: December 8, 2010
• First Posted Date: December 10, 2010
• Last Update Posted Date: November 9, 2012
• Study Start Date: March 2011
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 9, 2010)

Change from Baseline in BDNF levels at 4 weeks [ Time Frame: Baseline, Wk 4, Wk 8 ]

Blood samples will be assayed for brain-derived neurotrophic factor

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 9, 2010)

• Standardized, validated questionnaires querying mood and quality of life [ Time Frame: Baseline, Wk 4, Wk 8 ]
• Standardized, validated questionnaires regarding cognitive functioning [ Time Frame: Baseline, Wk 4, Wk 8 ]
• Change from Baseline in oxidative stress protein markers at 4 weeks [ Time Frame: Baseline, Wk 4, Wk 8 ]
  Blood samples will be assayed for oxidative stress protein markers (superoxide dismutase, catalase, glutathione peroxidase, and TBARS)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Oxidative Stress

Intervention

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

Study Arms

• Experimental: Lithia spring water
  Lithia water (active) for 4 weeks then placebo water for 4 weeks
  Intervention: Dietary Supplement: Lithia water
• Placebo Comparator: Natural spring water
  Placebo water for 4 weeks then lithia water (active) for 4 weeks
  Intervention: Dietary Supplement: Natural spring water with negligible lithium levels

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 7, 2012): 5
• Original Estimated Enrollment (submitted: December 9, 2010): 15
• Actual Study Completion Date: October 2012
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 19 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01257867
• Other Study ID Numbers: H10-03015
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of British Columbia
• Original Responsible Party: Raymond W. Lam, MD, FRCPC, Professor of Psychiatry, University of British Columbia
• Current Study Sponsor: University of British Columbia
• Original Study Sponsor: Same as current
• Collaborators: Aquaceutica Group

Investigators

• Principal Investigator: Raymond W Lam, MD, FRCPC; University of British Columbia

• PRS Account: University of British Columbia
• Verification Date: November 2012