Effects of Vitamin D-enriched mushrooms, Vitamin D and mushroom controls on cognition and mood in older adults

Phase 3

Active, not recruiting

• Conditions: Cognition; Vitamin D deficiency; Mood; Mental Health - Studies of normal psychology, cognitive function and behaviour; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12613000891729
• Lead Sponsor: CSIRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1) Healthy adults 60-90 years of age
2) Fluency in the English language (for valid completion of the cognitive test battery)
3) Agree to not commence any other form of oral Vitamin D supplementation throughout the duration of the study

Exclusion Criteria

1) Already taking Vitamin D supplements
2) Inability to swallow tablets
3) Physically unable to attend CSIRO cognitive laboratory/use a computer/pen and paper
4) 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)
5) Any of the following confounding factors affecting Vitamin D status: kidney disease or kidney function impairment; gastro-intestinal condition that interferes with nutrient absorption.

Study & Design

• Study Type: Interventional
• Study Design: Not specified