Status:
NOT_YET_RECRUITING
The Resistant Starch Intervention for Cognitive Enhancement
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Cognitive Impairment
Diet Interventions
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The investigation will explore the potential effects of resistant starch The Resistant Starch Intervention for Cognitive Enhancement study aimed to evaluate the effect of high-resistant starch diet in...
Detailed Description
The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk trial is designed to evaluate the effect of high-resistant starch diet intervention in slowing ...
Eligibility Criteria
Inclusion
- Patients aged ≥ 40 years
- meta-polygenic risk score (metaPRS) \> 0.4
- Montreal Cognitive Assessment (MoCA) score ≤ 26
- Central obesity (waist circumference \> 90 cm in males or \> 80 cm in females) or body mass index (BMI) ≥ 28 kg/m²
- Written informed consent available
- Proficient in using smartphones
- Willingness to complete all assessments and participate in follow-up
Exclusion
- Known hypersensitivity or allergy to resistant starch
- previously diagnosed dementia
- Suspected dementia after clinical assessment by study physician at screening visit
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- Severe loss of vision, hearing, or communicative ability
- Patients presenting a malignant disease with life expectancy \< 3 years
- Participation in an ongoing investigational drug study
- The participant or a first-degree relative is currently participating in another clinical trial involving nutritional intervention.
- Exit Criteria:
- Not meet the inclusion criteria
- For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
- Any adverse or serious adverse events during the study period judged by Investigator
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07152483
Start Date
September 1 2025
End Date
December 1 2026
Last Update
September 3 2025
Active Locations (1)
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1
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310009