Cognitive Decline, Cognitive Impairment, Diet Interventions, Genetic Risk Factors, Obesity &Amp; Overweight
Conditions
Keywords
Cognitive Impairment, Diet Interventions, Cognitive Decline, Genetic Risk Factors, Obesity & Overweight
Brief 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.
Interventions
DIETARY_SUPPLEMENTHigh resistant starch staple foods
Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
DIETARY_SUPPLEMENTRegular starch staple foods
Participants in the control group will intake isocaloric regular starch staple foods
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 months | Primary Outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 months | Secondary Outcome |
| Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) | 6 months | Secondary Outcome |
| Gut microbiota determined by measuring specific bacterial levels in the fecal samples | 6 months | Secondary Outcome |
| Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples | 6 months | Secondary Outcome |
| Change in waist circumference | 6 months | Secondary Outcome |
| Change in body mass index (BMI) | 6 months | Secondary Outcome |
| Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on diffusion tensor imaging (DTI) | 6 months | Secondary Outcome |
| Visual motor speed domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months | Secondary Outcome |
| Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI) | 6 months | Secondary Outcome |
| Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months | Secondary Outcome |
| Working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months | Secondary Outcome |
| Executive function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months | Secondary Outcome |
| Language domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months | Secondary Outcome |
| Visual spatial function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months | Secondary Outcome |
| Memory and recognition domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months | Secondary Outcome |
| Changes in image markers (white matter hyperintensity, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI | 6 months | Secondary Outcome |
Countries
China
Contacts
Primary ContactMin Lou, PhD, MD
Outcome results
None listed