NCT07152483Not yet recruiting
The Resistant Starch Intervention for Cognitive Enhancement
The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Obesity
- NCT number
- NCT07152483
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 1 Sept 2025 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previously diagnosed dementia
- Previous history of major head trauma and any intracranial surgery
- Participation in an ongoing investigational drug study
Other illness
- 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
Age
- Patients presenting a malignant disease with life expectancy \< 3 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affilated Hospital of Zhejiang University, School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.