The Resistant Starch Intervention for Cognitive Enhancement

NCT07152483 | Not Yet Recruiting

• 1 other identifier: RICE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

• Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

  6 months

• Gut microbiota determined by measuring specific bacterial levels in the fecal samples

  6 months

• Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples

  6 months

• Change in waist circumference

  6 months

Study Arms (2)

High-resistant starch foods intervention group

ACTIVE COMPARATOR

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

Regular starch staple foods control group

PLACEBO COMPARATOR

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

Dietary Supplement: Regular starch staple foods

Interventions

High resistant starch staple foods DIETARY_SUPPLEMENT

Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)

High-resistant starch foods intervention group

Regular starch staple foods DIETARY_SUPPLEMENT

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

Regular starch staple foods control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

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

Study Sites (1)

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Obesity; Overweight

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Min Lou, PhD, MD

CONTACT

13958007213; lm99@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)