Tests a resistant starch diet for cognitive decline in people at high genetic risk
Tests a high resistant starch diet in adults at high genetic risk of cognitive impairment.
Plain-language title generated from the registry record
Registry title: The Resistant Starch Intervention for Cognitive Enhancement
Key facts
- Where
- Hangzhou, ChinaSee the site
Where in China
- Second Affilated Hospital of Zhejiang University, School of MedicineHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07152483
- Record updated
- 3 September 2025
- Original description
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.Read full original descriptionShow less
The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk
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.
Inclusion: 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: previously diagnosed dementia; Previous history of major head trauma and any intracranial surgery; Participation in an ongoing investigational drug study; Known hypersensitivity or allergy to resistant starch; Suspected dementia after clinical assessment by study physician at screening visit; Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions; Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement; Patients presenting a malignant disease with life expectancy < 3 years; Severe loss of vision, hearing, or communicative ability; 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.