Micronutrients: What is the evidence?
Research has investigated the role of nutrition in the development of mental health issues (Davidson & Kaplan, 2012; O’Kennedy, 2016).
Individuals with poor mental health report nutrient-poor diets when compared to healthy controls (Kaplan et al, 2015; Davidson & Kaplan, 2012).
More recent trials have demonstrated efficacy of micronutrients in improving emotional regulation, reduce stress and improving attention/concentration and hyperactivity symptoms and improving insomnia with no adverse effects (Gariballa & Forster, 2007; Rucklidge et al, 2011; Rucklidge et al, 2014; Popper, 2014; Lothian et al, 2016).
The safety profile of micronutrient treatment in adults and children is reassuring (Simpson et al, 2011, Ruckldige et al, 2014).
What is the trial?
To test the effectiveness of micronutrients on symptoms of anxiety and depression in adults.
200 participants will be randomised to a placebo or treatment condition.
Participation is limited to people living in the Canterbury region.
The treatment condition will involve taking 12 micronutrient tablets per day (4 pills, 3 times a day) for 10 weeks.
The trial will also include a 2 week initial baseline phase, where no treatment or placebo will be offered.
Participants will complete initial assessment questionnaires and weekly monitoring of their symptoms.
At the conclusion of the trial, all participants will be offered micronutrients for a further 10 weeks in an open trial phase.
What is the intervention?
The micronutrient formula that will be used in the trial is Daily Essential Nutrients. The ingredients are as follows:
|Ingredients:||1 capsule||12 capsules|
|Vitamin A (as retinyl palmitate)||480 IU||5,760 IU|
|Vitamin C (as ascorbic acid)||50 mg||600 mg|
|Vitamin D (as cholecalciferol)||250 IU||3,000 IU|
|Vitamin E (as d-alpha tocopheryl succinate)||30 IU||360 IU|
|Vitamin K (75% as phylloquinone; 25% as menaquinone-7)||10 mcg||120 mcg|
|Thiamin (as thiamin mononitrate)||4 mg||60 mg|
|Riboflavin||1.5 mg||18 mg|
|Niacin (as niacinamide)||7.5 mg||90 mg|
|Vitamin B6 (as pyridoxine hydrochloride)||5.8 mg||69.9 mg|
|Folate (as L-methylfolate calcium)||66.8 mcg||801 mcg|
|Vitamin B12 (as methylcobalamin)||75 mcg||900 mcg|
|Biotin||90 mcg||1080 mcg|
|Pantothenic acid (as d-calcium pantothenate)||2.5 mg||30 mg|
|Calcium (as chelate)||110 mg||1,320 mg|
|Iron (as chelate)||1.15 mg||13.8 mg|
|Phosphorus (as chelate)||70 mg||840 mg|
|Iodine (as chelate)||17 mcg||204 mcg|
|Magnesium (as chelate)||50 mg||600 mg|
|Zinc (as chelate)||4 mg||48 mg|
|Selenium (as chelate)||17 mcg||204 mcg|
|Copper (as chelate)||0.6 mg||7.2 mg|
|Manganese (as chelate)||0.8 mg||9.6 mg|
|Chromium (as chelate)||52 mcg||624 mcg|
|Molybdenum (as chelate)||12 mcg||144 mcg|
|Potassium (as chelate)||20 mg||240 mg|
|Proprietary blend ingredients:|
|Acetylcarnitine (as acetyl-L-carnitine hydrochloride)|
|Grape seed extract|
|Ginkgo biloba leaf extract|
|Methionine (as L-methionine hydrochloride)|
|Cysteine (as N-acetyl-L-cysteine)|
|Germanium sesquioxide (as chelate)|
|Boron (as chelate)|
|Vanadium (as chelate)|
|Lithium orotate (as chelate)|
|Nickel (as chelate)|
The placebo formula ingredients are as follows:
|Ingredients:||1 capsule||12 capsules|
|Fiber Acacia Gum||300 mg||3,600 mg|
|Maltodextrin||395.90 mg||4,750.8 mg|
|Cocoa Powder||4 mg||48 mg|
|Riboflavin Powder||0.10 mg||1.2mg|
Inclusion and Exclusion criteria
1) between 18 and 65 years,
2) regular access to the internet,
3) considered reliable and compliant with the protocol (including the ingestion of as many as 12 capsules/day with food),
4) be presenting to their GP with functionally impairing anxiety or depressive symptoms which cannot be better accounted for by a medical condition,
5) and be living in the Canterbury area.
1) The main strict contraindications are metabolic conditions such as Wilson’s disease (copper), haemochromatosis (iron), phenylketonuira (phenylalanine) and trimethylaminuria (choline).
2) Neurological disorders involving brain or other central function (e.g., intellectual disability, autism spectrum disorder, epilepsy, MS, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder with associated suicidality, substance dependence or psychosis),
3) Any serious medical condition,
4) Any patient known to be allergic to the ingredients of the intervention (see above).
5) Any other medication with primarily central nervous system activity, including psychotropic medication (e.g. SSRIs, tricyclics, benzodiazepines). Participants must have been off of these medications for a minimum of four weeks prior to the trial. Participants are not encouraged to come off of a medication in order to participate in the trial. All exclusions will be reviewed by study physician.
6) There are some other medications that can have interactions with micronutrients (e.g. medication for thyroid conditions). Investigators will review potential participants’ medications for interactions and may decline participation in the trial if interactions exist. Please contact us for more information if you are concerned about potential interactions (contact details below).
7) Women who are pregnant or breastfeeding.