Non-pharmacological Intervention for Preclinical Alzheimer's Disease
Condition: Alzheimer Disease; Functional Food; Subjective Cognitive Decline; Intervention; Neuroimaging
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

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.
    

Intervention name(s): Mixed functional foods supplementation; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Subjective cognitive decline; Mixed functional foods; Non-pharmacologic intervention