The Resistant Starch Intervention for Cognitive Enhancement

N/ANot Yet RecruitingNCT07152483

Second Affiliated Hospital, School of Medicine, Zhejiang University70 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 6 months

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

Secondary Outcome

Time frame: 6 months

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

Secondary Outcome

Time frame: 6 months

Change in waist circumference

Secondary Outcome

Time frame: 6 months

Change in body mass index (BMI)

Secondary Outcome

Time frame: 6 months

Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on diffusion tensor imaging (DTI)

Secondary Outcome

Time frame: 6 months

Changes in image markers (white matter hyperintensity, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI

Secondary Outcome

Time frame: 6 months

Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)

Secondary Outcome

Time frame: 6 months

Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol (higher scores mean a better outcome)

Secondary Outcome

Time frame: 6 months

Working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

Secondary Outcome

Time frame: 6 months

Executive function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

Secondary Outcome

Time frame: 6 months

Language domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

Secondary Outcome

Time frame: 6 months

Visual motor speed domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

Secondary Outcome

Time frame: 6 months

Visual spatial function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

Secondary Outcome

Time frame: 6 months

Memory and recognition domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

Secondary Outcome

Time frame: 6 months

The Resistant Starch Intervention for Cognitive Enhancement

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts