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

NCT01257867 | Terminated

• 1 other identifier: H10-03015
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress

Keywords

Brain-derived neurotrophic factor; Oxidative stress; Neurogenesis; Lithium; Lithia water

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  Baseline, Wk 4, Wk 8

Study Arms (2)

Lithia spring water

EXPERIMENTAL

Lithia water (active) for 4 weeks then placebo water for 4 weeks

Dietary Supplement: Lithia water

Natural spring water

PLACEBO COMPARATOR

Placebo water for 4 weeks then lithia water (active) for 4 weeks

Dietary Supplement: Natural spring water with negligible lithium levels

Interventions

Lithia water DIETARY_SUPPLEMENT

Oral intake of approximately 2 litres (2L) daily for 4 weeks

Also known as: EDJ lithia spring water, (previous) Ilumati lithia spring water

Lithia spring water

Natural spring water with negligible lithium levels DIETARY_SUPPLEMENT

Oral intake of approximately 2 litres (2L) daily for 4 weeks

Natural spring water

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• See above

Sponsors & Collaborators

• University of British Columbia: lead
• Aquaceutica Group: collaborator

Study Sites (1)

University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, V6T 2A1, Canada

Location

Related Links

• University of British Columbia

Study Officials

• Raymond W Lam, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 10, 2010
• Study Start: March 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

CA (1)