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

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

Tracking Information
First Submitted Date  ICMJE December 8, 2010
First Posted Date  ICMJE December 10, 2010
Last Update Posted Date November 9, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT01257867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Oxidative Stress
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 7, 2012)
5
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2010)
15
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01257867
Other Study ID Numbers  ICMJE H10-03015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Aquaceutica Group
Investigators  ICMJE
Principal Investigator: Raymond W Lam, MD, FRCPC University of British Columbia
PRS Account University of British Columbia
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP