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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Regular starch staple foods control group | Placebo Comparator | Participants in the control group will intake isocaloric regular starch staple foods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Exit Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Lou, PhD, MD | Contact | 13958007213 | lm99@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affilated Hospital of Zhejiang University, School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| Regular starch staple foods | Dietary Supplement | Participants in the control group will intake isocaloric regular starch staple foods |
|
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 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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