About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- High resistant starch staple foods
- Regular starch staple foods