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Набор скоро начнётся NCT07152483

The Resistant Starch Intervention for Cognitive Enhancement

Без фазы С лечением Cognitive Impairment Diet Interventions Cognitive Decline Genetic Risk Factors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High resistant starch staple foods, Regular starch staple foods.
Кому может быть актуально
Состояния в реестре: Cognitive Impairment, Diet Interventions, Cognitive Decline, Genetic Risk Factors. Базовые параметры: от 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk

Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка High resistant starch staple foods
    Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
  • Пищевая добавка Regular starch staple foods
    Participants in the control group will intake isocaloric regular starch staple foods

Первичные конечные точки

  • 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) [Срок оценки: 6 months]
Вторичные конечные точки (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) [Срок оценки: 6 months]
  • Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) [Срок оценки: 6 months]
  • Gut microbiota determined by measuring specific bacterial levels in the fecal samples [Срок оценки: 6 months]
  • Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples [Срок оценки: 6 months]
  • Change in waist circumference [Срок оценки: 6 months]
  • Change in body mass index (BMI) [Срок оценки: 6 months]
  • Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on diffusion tensor imaging (DTI) [Срок оценки: 6 months]
  • Changes in image markers (white matter hyperintensity, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI [Срок оценки: 6 months]
  • Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI) [Срок оценки: 6 months]
  • Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol (higher scores mean a better outcome) [Срок оценки: 6 months]
  • Working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) [Срок оценки: 6 months]
  • Executive function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Second Affilated Hospital of Zhejiang University, School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07152483 · RICE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗