Clinical trial

The Resistant Starch Intervention for Cognitive Enhancement

Opening soon · Not applicable · 1 countries · Registry ID NCT07152483

Opening soonNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionCognitive Impairment, Diet Interventions, Cognitive Decline, Genetic Risk Factors, Obesity &Amp; Overweight

Full registry 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

Treatments and study arms

High resistant starch staple foods

Dietary Supplement

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

Regular starch staple foods

Dietary Supplement

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

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Second Affilated Hospital of Zhejiang University, School of Medicine🇨🇳 Hangzhou, Zhejiang, China
Min Lou, PhD, MDContact