Cognitive Effects of Bioavailable Curcumin
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 240
- 主要终点
- Memory
研究概览
简要总结
An estimated 50% of older adults complain of memory changes that worsen as they age. Although numerous commercially available dietary supplements claim cognitive benefits, relatively few well-designed, longitudinal, placebo-controlled studies have rigorously evaluated their effects on cognitive performance.
In a previous double-blind, randomized, placebo-controlled, 18-month clinical trial in middle-aged and older non-demented adults, the investigators found that a bioavailable form of curcumin taken orally twice a day showed greater gains on specific measures of memory and attention relative to placebo. Although the investigators found significant between-group curcumin/placebo differences with moderate effect sizes, the sample size (n=40) was small. The present adequately powered, randomized, double-blind, placebo-controlled study will evaluate the effect of daily consumption of bioavailable curcumin on measurable changes in cognitive performance in non-demented middle-aged and older adults.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of age-related memory complaints;
- •Male or female aged 50 to 85 years of age at Visit
- •performance on MoCA test of >= 18 (Milani et al, 2018)
- •Ability to perform normal daily activities independently (which excludes a diagnosis of dementia).
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- •Agreement to participate in the entire study, which could last either 6 or 12 months depending on results of the interim analysis.
- •Adequate visual and auditory acuity for cognitive testing.
- •Screening laboratory tests that do not show significant medical problems that might interfere with study participation or impact cognitive test results.
- •Psychotropic medication, if used, should be stable for at least 2 weeks prior to randomization.
- •Agreement to avoid taking any curcumin, turmeric supplements or cognitive enhancing medicines or supplements during the course of the study.
排除标准
- •Allergy to curcumin
- •Presence of a condition or abnormality that in the opinion of the site Principal Investigator would compromise the safety of the patient or the quality of the data.
- •Significant cerebrovascular disease or Alzheimer disease or any other dementia.
- •Neurological or physical illnesses that can produce cognitive deterioration.
- •History of myocardial infarction within the previous year or unstable cardiac disease.
- •Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100); significant liver or pulmonary disease, or cancer;
- •Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria with a change in medication or clinical symptoms with the last 3 months prior to screening (APA, 2000).
- •History of alcoholism or substance addiction in the last 15 years.
- •Current treatment for seizure disorder;
- •Abnormal laboratory values with clinical significance in the opinion of the site Principal Investigator.
- •Current unstable medical illness including delirium, worsening congestive heart failure, unstable angina, recent myocardial infarctions, acute infectious disease, severe renal or hepatic failure, severe respiratory disease, metastatic cancer, or other conditions that, in the Principal Investigator's opinion, could interfere with the analysis of safety and efficacy in this study.
- •A 2-week washout is required prior to baseline for any of the following: curcumin or turmeric supplements, any anti-inflammatory medication other than occasional use (e.g., once per week).
- •The subject may not be an immediate family member (e.g., spouse, parent, child, sibling) of personnel directly affiliated with this study, the study site or study funding agency.
研究组 & 干预措施
Theracurmin Super TS-P1 capsules containing 75 mg in total of curcumin will be administered orally)
干预措施: Curcumin (Dietary Supplement)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Memory
时间窗: 12 months
The primary endpoint will be a memory domain score calculated from the Consistent Long Term Recall score of the Buschke Selective Reminding Test (SRT)
次要结局
- Cognitive function test(12 months)
- PROMIS Cognitive Function(12 months)
- Self-reported depression symptoms(12 months)
- Blood levels of curcumin(12 months)
- Inflammation and neurodegenerative markers(12 months)
- metabolic markers(12 months)
- Quality of life(12 months)
- Body composition(12 months)
- APOE-4 carrier status(12 months)
- Sleep quality(12 months)
- Fatigue(12 months)
- The Trail Making Test (TMT)(12 months)
- Verbal Fluency Test(12 months)
- Category Fluency Test(12 months)
研究者
Zhaoping Li
Professor of Medicine and Chief of the Division of Clinical Nutrition at the University of California, Los Angeles
University of California, Los Angeles