Trial record 1 of 1 for:    NCT01257867
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Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants

This study has been terminated.
(This study was terminated by the Principal Investigator)
Sponsor:
Collaborator:
Aquaceutica Group
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01257867
First received: December 8, 2010
Last updated: November 7, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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:
  • 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

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257867

Locations
Canada, British Columbia
University of British Columbia, Department of Psychiatry
Vancouver, British Columbia, Canada, V6T 2A1
Sponsors and Collaborators
University of British Columbia
Aquaceutica Group
Investigators
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 April 17, 2014