The Resistant Starch Intervention for Cognitive Enhancement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High resistant starch staple foods, Regular starch staple foods.
- Who it may be relevant to
- Registry conditions: Cognitive Impairment, Diet Interventions, Cognitive Decline, Genetic Risk Factors. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk
Overview
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.
Interventions
- 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
Primary outcome measures
- Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome) [Time frame: 6 months]
Secondary outcome measures (12)
- Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome) [Time frame: 6 months]
- Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) [Time frame: 6 months]
- Gut microbiota determined by measuring specific bacterial levels in the fecal samples [Time frame: 6 months]
- Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples [Time frame: 6 months]
- Change in waist circumference [Time frame: 6 months]
- Change in body mass index (BMI) [Time frame: 6 months]
- Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on diffusion tensor imaging (DTI) [Time frame: 6 months]
- Changes in image markers (white matter hyperintensity, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI [Time frame: 6 months]
- Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI) [Time frame: 6 months]
- Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol (higher scores mean a better outcome) [Time frame: 6 months]
- Working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) [Time frame: 6 months]
- Executive function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- Severe loss of vision, hearing, or communicative ability
- Patients presenting a malignant disease with life expectancy < 3 years
- Participation in an ongoing investigational drug study
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Second Affilated Hospital of Zhejiang University, School of Medicine — Hangzhou
Identifiers
NCT: NCT07152483 · RICE