The Resistant Starch Intervention for Cognitive Enhancement

Zhejiang University

Status: Not yet enrolling

Conditions: Obesity &Amp; Overweight; Genetic Risk Factors; Diet Interventions; Cognitive Impairment; Cognitive Decline

Treatments: Dietary Supplement: Regular starch staple foods; Dietary Supplement: High resistant starch staple foods

Study type: Interventional

Funder types: Other

Identifiers

NCT07152483

RICE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

High-resistant starch foods intervention group

Active Comparator group

Description:

Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)

Treatment:

Dietary Supplement: High resistant starch staple foods

Regular starch staple foods control group

Placebo Comparator group

Description:

Participants in the control group will intake isocaloric regular starch staple foods

Treatment:

Dietary Supplement: Regular starch staple foods