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.
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
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
Parallel
High resistant starch staple foods
Dietary supplementParticipants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
Regular starch staple foods
Dietary supplementParticipants in the control group will intake isocaloric regular starch staple foods
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
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
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Secondary Outcome
Gut microbiota determined by measuring specific bacterial levels in the fecal samples
Secondary Outcome
Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples
Secondary Outcome
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