The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High-resistant starch foods intervention group
Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
干预措施: High resistant starch staple foods (Dietary Supplement)
Regular starch staple foods control group
Participants in the control group will intake isocaloric regular starch staple foods
干预措施: Regular starch staple foods (Dietary Supplement)
结局指标
主要结局
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)
时间窗: 6 months
Primary Outcome
次要结局
- Change in body mass index (BMI)(6 months)
- 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)
- Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)(6 months)
- Working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)(6 months)
- Gut microbiota determined by measuring specific bacterial levels in the fecal samples(6 months)
- Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples(6 months)
- Change in waist circumference(6 months)
- Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on diffusion tensor imaging (DTI)(6 months)
- Changes in image markers (white matter hyperintensity, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI(6 months)
- Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)(6 months)
- Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol (higher scores mean a better outcome)(6 months)
- Executive function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)(6 months)
- Language domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)(6 months)
- Visual motor speed domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)(6 months)
- Visual spatial function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)(6 months)
- Memory and recognition domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)(6 months)