Trials / Not Yet Recruiting
Not Yet RecruitingNCT07152483
The Resistant Starch Intervention for Cognitive Enhancement
The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | High resistant starch staple foods | Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch) |
| DIETARY_SUPPLEMENT | Regular starch staple foods | Participants in the control group will intake isocaloric regular starch staple foods |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2026-04-01
- Completion
- 2026-12-01
- First posted
- 2025-09-03
- Last updated
- 2025-09-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07152483. Inclusion in this directory is not an endorsement.