NCT04279418

Non-pharmacological Intervention for Preclinical Alzheimer's Disease

Effects of Mixed Functional Foods Supplementation on Cognition and Neuroimaging Biomarkers in Adults With Subject Cognitive Decline

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: XuanwuH 2 · Academic / Other
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective drugs targeting this disease. Functional food is considered as a potentially non-pharmacologic treatment. In this project, the investigators aim to investigate the effectiveness of a mixed functional food with main compositions of ginsenoside, green tea polyphenols and marine collagen peptide on cognition for individuals with subjective cognitive decline (SCD). Taking the randomized, double-blind, placebo-controlled method, participants in the functional food group will take mixed functional foods for three months and those in the placebo group will take placebo. After that, the investigators will investigate the changes of cognitive function. Furthermore, based on the neuroimaging technique, the regulatory mechanism of functional food in intervening SCD will be revealed from the perspective of altered brain functional activity. In conclusion, these results are beneficial for understanding the therapeutic effect of mixed functional foods as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.

Detailed description

Currently, there has been no effective therapy for Alzheimer's disease (AD). Functional food is now considered as a potentially non-pharmacologic intervention and supplementation of functional food may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of mixed functional foods with multiple compositions on cognition and neuroimaging biomarkers for subjective cognitive decline (SCD). Sixty participants with SCD will be recruited in this three-month, randomized, double-blind, placebo-controlled trial. Each group had thirty participants. Participants in the functional food group will take mixed functional foods for three months and those in the placebo group will take placebo. After that, the investigators will investigate the changes of memory measures, which is the primary outcome. Furthermore, based on the neuroimaging technique of functional near-infrared spectroscopy (fNIRS), the regulatory mechanism of mixed functional foods in intervening SCD will be revealed from the perspective of altered brain functional activity. In conclusion, these results are beneficial for understanding the therapeutic effect of mixed functional foods as a non-drug therapy for preclinical AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.

Conditions

• Alzheimer Disease
• Functional Food
• Subjective Cognitive Decline
• Intervention
• Neuroimaging

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mixed functional foods supplementation	In this project, taking the method of random, double blindness and control, participants in the mixed functional foods group will take functional foods with main compositions of ginsenoside, green tea polyphenols and marine collagen peptide for three months. After that, neuropsychological tests and neuroimaging biomarkers will be compared between functional food group and placebo group.
DIETARY_SUPPLEMENT	Placebo	In this project, taking the method of random, double blindness and control, participants in the placebo group will take placebo for three months. After that, cognitive changes and neuroimaging biomarkers will be compared between functional food group and placebo group.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-08-31
• Completion: 2019-12-31
• First posted: 2020-02-21
• Last updated: 2020-02-21

Locations

1 site across 1 country: China