Oxidative StressNCT01257867
Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants
A study testing Lithia water and Natural spring water with negligible lithium levels in people with Oxidative Stress, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Lithia water and Natural spring water with negligible lithium levels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- See above
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Department of Psychiatry
Vancouver, British Columbia, V6T 2A1
About this study
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.
Read the 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.
- Conditions
- Oxidative Stress
- Being tested
- Lithia water, Natural spring water with negligible lithium levels
- Keywords
- Brain-derived neurotrophic factor, Oxidative stress, Neurogenesis, Lithium, Lithia water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithia waterDietary supplement
Also called EDJ lithia spring water, (previous) Ilumati lithia spring water
Oral intake of approximately 2 litres (2L) daily for 4 weeks
Natural spring water with negligible lithium levelsDietary supplement
Oral intake of approximately 2 litres (2L) daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lithia spring water | Experimental | Lithia water (active) for 4 weeks then placebo water for 4 weeks Receives: Dietary Supplement: Lithia water |
| Natural spring water | Placebo comparator | Placebo water for 4 weeks then lithia water (active) for 4 weeks Receives: Dietary Supplement: Natural spring water with negligible lithium levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in BDNF levels at 4 weeks
Blood samples will be assayed for brain-derived neurotrophic factor
Measured: Baseline, Wk 4, Wk 8
Secondary outcomes (3)
Standardized, validated questionnaires querying mood and quality of life
Measured: Baseline, Wk 4, Wk 8
Standardized, validated questionnaires regarding cognitive functioning
Measured: 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)
Measured: Baseline, Wk 4, Wk 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: This study was terminated by the Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Aquaceutica Group
- Responsible party
- Sponsor
- Investigators
- Raymond W Lam, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257867
- Sponsor's protocol ID
- H10-03015
- Status last verified
- Nov 2012
- First submitted
- 8 Dec 2010
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT01257867
- Acronym / sponsor ID
- H10-03015
- Conditions
- Oxidative Stress
- Keywords
- Brain-derived neurotrophic factor, Oxidative stress, Neurogenesis, Lithium, Lithia water
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated by the Principal Investigator
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Aquaceutica Group
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithia spring water | Experimental | Dietary Supplement: Lithia waterLithia water (active) for 4 weeks then placebo water for 4 weeks |
| Natural spring water | Placebo comparator | Dietary Supplement: Natural spring water with negligible lithium levelsPlacebo water for 4 weeks then lithia water (active) for 4 weeks |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- See above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithia waterAlso: EDJ lithia spring water, (previous) Ilumati lithia spring waterOral intake of approximately 2 litres (2L) daily for 4 weeks | Dietary supplement | Lithia spring water |
| Natural spring water with negligible lithium levelsOral intake of approximately 2 litres (2L) daily for 4 weeks | Dietary supplement | Natural spring water |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: This study was terminated by the Principal Investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
- University of British ColumbiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond W Lam, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithia water and Natural spring water with negligible lithium levels in people with Oxidative Stress, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was terminated by the Principal Investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in BDNF levels at 4 weeks (time frame: Baseline, Wk 4, Wk 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2012.