An interventional study of Hericium erinaceus and Placebo in Cognitive Decline, Mild, sponsored by University of Primorska. Completed at 1 site in Slovenia. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by University of Primorska · Not applicable, Interventional, and Prevention
The study evaluates the effects of Hericium erinaceus on microbiota, cognition, and other health parameters in older adults. All measurements will be performed at baseline and ten weeks after daily consumptions of either Hericium erinaceus or placebo.
Hericium erinaceus, a well-known edible mushroom, has numerous biological activities. Yamabushitake (Hericium erinaceus) is a mushroom that grows on both living and dead broadleaf trees. Yamabushitake is used as food in Japan and China. Hericenones and erinacines stimulate nerve growth factor synthesis, and therefore it is expected that H. erinaceus have some effects on brain functions and autonomic nervous system. Hericium was tested in several applications, such as dementia, Alzheimer's disease, Parkinson's disease, multiple sclerosis, neuropathy and neurasthenia. The ancient Chinese knew about these possibilities and used it to support mental functions and memory, concentration. It is also very good for various digestive problems, such as gastritis, stomach ulcers, heartburn, reflux and improvement of digestion.
Therefore, the aim of our study is to evaluate the effects of Hericium erinaceus on microbiota, cognition and related parameters in elderly. The stool samples will be taken at baseline and after ten weeks of daily consumption of Hericium erinaceus or placebo. In addition, cognitive tests, anthropometric measurements, and blood analysis (lipid profile, glucose levels and neurotrophic factors) will be measured at the same time points.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 40 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Primorska is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
8 gram of mushroom Hericium erinaceus (containing 5 milligram of erinacines) per day
Dietary Supplement: Hericium erinaceus
8 gram of allergen free corn starch per day
Dietary Supplement: Placebo
6 capsules per day, 3 times two after breakfast, lunch and dinner
6 capsules per day, 3 times two after breakfast, lunch and dinner
Assessment of the microbial community composition in feces samples using next-generation sequencing
For the assessment of the microbial community composition, DNA will be extracted from the frozen faecal samples (1-2 gram) with the commercial DNA Stool Mini Kit. A comparison of microbiota among treatments will be done with a meta-barcoding approach using ribosomal RNA markers with modified primers.
Time frame: Change from Baseline Microbiota composition at 10 weeks.
cognitive function
Test of perception speed patterns, Test of series
Time frame: Change from baseline Cognitive function at 10 weeks.
brain derived neurotrophic factor
serum level measured with ELISA assay
Time frame: Change from baseline Brain derived neurotrophic factor levels at 10 weeks.
neuropeptide Y
serum level measured with ELISA assay
Time frame: Change from baseline Neuropeptide Y levels at 10 weeks.
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Primorska