The Resistant Starch Intervention for Cognitive Enhancement

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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

Treatment groups

70 Participants
are divided into 2 treatment groups