None listed
Conditions
Brief summary
This study aims to look at the effect that a micronutrient formula (vitamins and minerals) has on symptoms of insomnia. Previous research has shown that these nutrients can lower levels of anxiety, stress and intrusive thoughts in participants. Since these symptoms are often reported by insomniacs, it is hypothesised that a reduction in these symptoms may also lead to reduction in symptoms of insomnia.
Interventions
Intervention is supplementation with a micronutrient formula distributed by Optimus nutraceuticals. The brand name of the micronutrient formula is "Daily Self Defense". The micronutrient formula will be taken in capsule form, at a dose of 6 capsules per day (two equal doses of 3) during the 8 week treatment phase. Adherence to taking the capsules will be monitored in the daily sleep diary completed by participants where they will fill out a question about how many capsules they took that day.
T
Intervention is supplementation with a micronutrient formula distributed by Optimus nutraceuticals. The brand name of the micronutrient formula is "Daily Self Defense". The micronutrient formula will be taken in capsule form, at a dose of 6 capsules per day (two equal doses of 3) during the 8 week treatment phase. Adherence to taking the capsules will be monitored in the daily sleep diary completed by participants where they will fill out a question about how many capsules they took that day. The ingredients contained in a 6 capsule dose are as follows: Vitamin A (as retinyl palmitate)4000 IU, Vitamin C (as ascorbic acid) 300 mg, Vitamin D (as cholecalciferol) 3000 IU, Vitamin E (as d-alpha tocopheryl succinate) 261.9 IU, Vitamin K1 (as phylloquinone) 90 mcg, Vitamin K2 (as menaquinone-7) 30 mcg, Thiamin (as thiamin mononitrate)60 mg, Riboflavin 16 mg, Niacin (as niacinamide)52 mg, Vitamin B6 (as pyridoxine hydrochloride) 60 mg, Folate (as folic acid) 400 mcg, Folate (as L-methylfolate calcium) 400 mcg, Vitamin B12 (as methylcobalamin) 400 mcg, Biotin 378 mcg, Pantothenic acid (as d-calcium pantothenate 30 mg, Calcium (as chelate) 485 mg, Iron (as chelate) 18 mg, Phosphorus (as chelate) 309.1 mg, Iodine (as chelate) 240 mcg, Magnesium (as chelate) 220.8 mg, Zinc (as chelate) 17.7 mg, Selenium (as chelate) 75 mcg, Copper (as chelate) 2.6 mg, Manganese (as chelate) 3.5 mg, Chromium (as chelate) 229.8 mcg, Molybdenum (as chelate) 52.8 mcg, Potassium (as chelate) 88.3 mg, Choline bitartrate 172.2 mg, Shilajit 75.0 mg, Spirulina 66 mg, Larch arabinogalactan 66 mg, Inositol 57.4 mg, Rhodiola rosea root extract 40 mg, Astragalus root extract 36 mg, Royal jelly 3X 24 mg, Grape seed extract 14.4 mg, Ginkgo biloba leaf extract 11.5 mg, Germanium sesquioxide (as chelate)7.6 mg, Boron (as chelate) 883.2 mcg, Vanadium (as chelate) 439.4 mcg, Lithium orotate (as chelate) 368.2 mcg, Nickel (as chelate) 11.0 mcg, Cellulose 331.2 mg, Glycine 270 mg, Citric acid 160.9 mg, Magnesium stearate 144 mg, Silicon dioxide 120 mg
Sponsors
University of Canterbury
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must be 18 years or over, be classified as having a diagnosis of 'insomnia' according to the Pittsburgh Insomnia Symptom Questionnaire which they complete during the screening process, and scores in the 'moderate' or 'severe' range for insomnia symptoms on the Piitsburgh Insomnia Rating Scale.
Exclusion criteria
Participants must not be taking psychotropic medciations (eg antidepressants, anxiolytics) or prescribed sleep medications. They must not be pregnant or breastfeeding, and must not have a child two years or under. They must not have sleep apnoea. They will be asked to not take any other products for assisting with sleep during the course of the trial.
Outcome results
None listed