The Resistant Starch Intervention for Cognitive Enhancement

NCT ID: NCT07152483

Last Updated: 2025-09-03

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-12-01

Brief Summary

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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

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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.

Conditions

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Cognitive Impairment Diet Interventions Cognitive Decline Genetic Risk Factors Obesity &Amp; Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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)

Group Type ACTIVE_COMPARATOR

High resistant starch staple foods

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Regular starch staple foods

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DIETARY_SUPPLEMENT

Regular starch staple foods

Participants in the control group will intake isocaloric regular starch staple foods

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Exit Criteria:
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Min Lou, PhD, MD

Role: CONTACT

13958007213

Facility Contacts

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Min Lou, PhD, MD

Role: primary

13958007213

Other Identifiers

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RICE

Identifier Type: -

Identifier Source: org_study_id

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