The Resistant Starch Intervention for Cognitive Enhancement
NCT ID: NCT07152483
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2025-09-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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High-resistant starch foods intervention group
Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
High resistant starch staple foods
Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
Regular starch staple foods control group
Participants in the control group will intake isocaloric regular starch staple foods
Regular starch staple foods
Participants in the control group will intake isocaloric regular starch staple foods
Interventions
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High resistant starch staple foods
Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
Regular starch staple foods
Participants in the control group will intake isocaloric regular starch staple foods
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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:
40 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RICE
Identifier Type: -
Identifier Source: org_study_id
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