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The Resistant Starch Intervention for Cognitive Enhancement

The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk

NCT07152483•Second Affiliated Hospital, School of Medicine, Zhejiang University

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 intervention in slowing cognitive decline among individuals at high genetic risk for cognitive impairment. Participants will be randomly assigned to either an intervention group receiving daily high-resistant starch food products or a control group receiving isoenergetic regular starch products. The investigation will validate the potential effects of resistant starch on cognitive function protection and explore the underlying mechanisms through comprehensive data collection, including standardized neuropsychological assessments, laboratory biomarkers derived from blood and fecal specimens, and multimodal magnetic resonance imaging.

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 cognitive decline among individuals at high genetic risk for cognitive impairment. A total of 70 participants aged ≥40 years with a meta-polygenic risk score (metaPRS) \>0.4-indicating elevated genetic susceptibility-and who are overweight or abdominally obese, will be randomly assigned in a 1:1 ratio to either an intervention group receiving daily high-resistant starch food products (≥28 g/day) or a control group receiving isoenergetic regular starch products. The investigation will validate the potential effects of resistant starch on cognitive function protection and explore the underlying mechanisms through comprehensive data collection, including standardized neuropsychological assessments, laboratory biomarkers derived from blood and fecal specimens, and multimodal magnetic resonance imaging.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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

•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.
+1 more criteria

Locations (1)

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

September 1, 2025

Primary Completion Date

April 1, 2026

Completion Date

December 1, 2026

Last Updated

September 3, 2025

Enrollment

ESTIMATED participants

Conditions

Cognitive ImpairmentDiet InterventionsCognitive DeclineGenetic Risk FactorsObesity &Amp; Overweight

Interventions

High resistant starch staple foods

DIETARY_SUPPLEMENT

Regular starch staple foods

DIETARY_SUPPLEMENT

Contacts

Min Lou, PhD, MD

CONTACT

13958007213 lm99@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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The Resistant Starch Intervention for Cognitive Enhancement

Inclusion Criteria

Exclusion Criteria

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