Effects of Vitamin D-enriched mushrooms, Vitamin D and mushroom controls on cognition and mood in older adults
Randomised clinical trial testing effects of Vitamin D-enriched mushroom, Vitamin D and mushroom controls on cognition and mood in a healthy aged population.
CSIRO
600 participants
Apr 1, 2014
Interventional
Conditions
Summary
Vitamin D deficiency is prevalent in the elderly and Vitamin D status has been correlated with cognitive performance in a number of epidemiological studies. However, the potential benefit of correcting Vitamin D status on cognition is unknown. The Vitamin D content of mushrooms can be increased to biologically useful levels by a short exposure time to UV light. The aim of this study is to determine if increasing vitamin D status by consumption of either Vitamin D2-enriched mushrooms (VDM) or Vitamin D3 supplement, will improve cognitive function and affect depressive symptoms in healthy aged people (Primary Outcomes). Controls will include a placebo and also standard mushrooms (low Vitamin D) so as to resolve the effects of Vitamin D2 per se from other mushroom-derived nutrients, including micro-nutrients and neurotrophic factors, which have some evidence for benefits to cognition per se.
Eligibility
Inclusion Criteria3
- Healthy adults 60-90 years of age
- Fluency in the English language (for valid completion of the cognitive test battery)
- Agree to not commence any other form of oral Vitamin D supplementation throughout the duration of the study
Exclusion Criteria5
- Already taking Vitamin D supplements
- Inability to swallow tablets
- Physically unable to attend CSIRO cognitive laboratory/use a computer/pen and paper
- Any of the following confounding factors affecting cognitive status: diagnosed with intellectual disability, dementia; untreated depression (identified at screening using the CES-D questionnaire; score > 16); score < 24 on the MMSE at screening, neurological disorder including but not limited to cerebral vascular disease, have had head injury, stroke, coronary artery bypass surgery, history of alcohol or drug abuse, metabolic disease including diabetes, untreated asthma, shift workers, people who habitually sleep < 6 hrs a night, or those with untreated obstructive sleep apnoea (identified at screening using OSA 50 questionnaire), untreated depression (unless taking SSRI medication and stabilised for >6 months), abnormal thyroid function (hypo, hyper), abnormal Vitamin B12 status, history of psychosis and/or taking anti-psychotic medication, history of epilepsy and/or taking anti-epileptic medication, prior significant head injury or neurosurgical procedure, past participation in the EPOCH Trial (ACTRN12607000278437)
- Any of the following confounding factors affecting Vitamin D status: kidney disease or kidney function impairment; gastro-intestinal condition that interferes with nutrient absorption.
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Interventions
Participants will be asked to take one capsule of either of the following every day for 6 months: 1) Vitamin D-enriched Button mushroom solids (500 mg, including 600 IU of Vitamin D) in a cellulose carrier 2) 600 IU of Vitamin D in a cellulose carrier 3) Standard Button mushroom solids (500 mg) in a cellulose carrier 4) Placebo (cellulose carrier alone) Participants will present to the CSIRO Clinic at baseline, 6 weeks and 6 months to donate a blood sample and undergo cognitive testing. In addition, a buccal cell scrape will be performed at baseline. Prior to presenting to the clinic at the nominated time points, participants will be asked to complete mail-out questionnaires. Adherence will be monitored as follows: participants will be provided with a calendar to mark any days they forget to take a capsule and will be asked to return the capsule bottle (containing any remaining capsules) at the end of the intervention.
Locations(1)
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ACTRN12613000891729