None listed
Conditions
Brief summary
The purpose of the study is to investigate whether micronutrients can reduce stress and anxiety associated with the Christchurch earthquakes. Two formulas are being compared with one at two different doses.
Interventions
We will be randomizing participants to one of three conditions: 1) Berocca Performance (oral capsule, 1 a day), a 16 ingredient micronutrient formula, 2) EMPowerplus (4 oral pills once a day) a 36 ingredient micronutrient formula, or 3) EMPoweprlus (8 oral pills - 4 twice a day) for a 4 week period with natural follow up.
Sponsors
University of Canterbury
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: Participants must have been in Christchurch at the time of at least one of the major earthquakes (September 4th 2010 or February 22nd 2011). They must be free of psychotropic medications for the trial. Further, they must be over 18 years of age, possess a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol (including the ingestion of as many as 8 capsules/day), and must be able to eat at least a snack twice per day. They must also have at least one score above the cutoffs of the Depression, Anxiety and Stress Scale: Cutoffs have been provided to indicate mild, moderate or severe problems; anything below 13 (for depression), 10 (for anxiety) and 18 (for stress) is considered within the normal to mild range.
Exclusion criteria
Participants will be excluded from the study for any of the following reasons: 1. Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy). Purely peripheral neurological problems are not excluded (e.g., Raynaud’s, peripheral diabetic neuropathy). 2. Any serious medical condition for which major medical interventions are anticipated during the duration of the trial. 3. Any participant known to be allergic to the ingredients of the intervention (including ginkgo biloba, germanium sesquioxide, or grape seed) will be excluded. 4. Pregnant or breastfeeding. 5. Evidence of untreated or unstable thyroid disease (based on interview) 6. Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis). 7. Any other medication with primarily central nervous system activity, including mood stabilizers. Participants must have been off of these medications for a minimum of four weeks prior to the trial. 8. Participants will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. 9. Any type of nutritional or herbal supplement, known to have a centrally-acting effect, will result in a participant's exclusion. However, participants who have been taking supplements such as echinacea, chondroitin, or glucosamine may enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continue on these agents throughout the study. We will permit people to take as much as 1 g/day of EPA and DHA combined. 10. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.
Outcome results
None listed