The Resistant Starch Intervention for Cognitive Enhancement

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07152483
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study Start: 2025-09-01
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2026-04-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)	6 months	Primary Outcome

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Second Affilated Hospital of Zhejiang University, School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China