The Resistant Starch Intervention for Cognitive Enhancement

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Cognitive Decline; Genetic Risk Factors; Diet Interventions; Obesity &Amp; Overweight
• Intervention / Treatment: Dietary supplement: High resistant starch staple foods; Dietary supplement: Regular starch staple foods

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Lou, PhD, MD; Phone Number: 13958007213; Email: lm99@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affilated Hospital of Zhejiang University, School of Medicine
      • Contact: Min Lou, PhD, MD; Phone Number: 13958007213; Email: lm99@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Dietary supplement: High resistant starch staple foods; Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
Placebo Comparator: Regular starch staple foods control group; Participants in the control group will intake isocaloric regular starch staple foods	Dietary supplement: Regular starch staple foods; Participants in the control group will intake isocaloric regular starch staple foods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)	Primary Outcome	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)	Secondary Outcome	6 months
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	Secondary Outcome	6 months
Gut microbiota determined by measuring specific bacterial levels in the fecal samples	Secondary Outcome	6 months
Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples	Secondary Outcome	6 months
Change in waist circumference	Secondary Outcome	6 months
Change in body mass index (BMI)	Secondary Outcome	6 months
Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on diffusion tensor imaging (DTI)	Secondary Outcome	6 months
Changes in image markers (white matter hyperintensity, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI	Secondary Outcome	6 months
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)	Secondary Outcome	6 months
Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol (higher scores mean a better outcome)	Secondary Outcome	6 months
Working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)	Secondary Outcome	6 months
Executive function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)	Secondary Outcome	6 months
Language domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)	Secondary Outcome	6 months
Visual motor speed domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)	Secondary Outcome	6 months
Visual spatial function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)	Secondary Outcome	6 months
Memory and recognition domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)	Secondary Outcome	6 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 26, 2025
• First Submitted That Met QC Criteria: August 26, 2025
• First Posted (Estimated): September 3, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Cognitive Decline; Genetic Risk Factors; Diet Interventions; Obesity & Overweight
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Cognitive Dysfunction
• Other Study ID Numbers: RICE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No