Effect of Daily Mixed Spice Consumption on Memory in Middle-Aged and Older Adults With Age-related Cognitive Decline: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Memory
研究概览
简要总结
The aging process entails a multitude of structural and functional alterations within the brain, culminating in a gradual and progressive decline in cognitive function. Recent research has indicated that various spices may hold the key to enhancing brain health and combating the effects of aging on cognitive abilities. The hypothesis is that a mixture of spices, acknowledged for their reported memory protection potential, may yield a more potent beneficial effect on memory function than a single spice. The spice mixture will be used at culinary dose, and therefore side effects are anticipated. In this study, the effects of spice mixture will be evaluated, as well as their anti-oxidant, and anti-inflammatory properties. The proposed pilot study will include 50 adults (ages 50-80), exhibiting typical age-related mild cognitive decline, excluding dementia or major neurocognitive disorders. They will be randomized 1:1 assigned into a daily intake of either 4.00 g spice mixture capsules or 4.00 g maltodextrin capsules over 3 months, and explore the sustainable effect over 3 additional months. The changes in symptoms of cognition, fatigue, and mood symptoms of the spice group vs. placebo group will be compared. The outcome of the investigation of the effects of mixed spice consumption will provide important novel information on dietary recommendation of spice to preserve cognitive function in aging population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are required to have clinical histories consistent with normal aging or mild cognitive impairment (MCI).
- •Age 50 to 80 years.
- •Adequate visual acuity and hearing to allow neuropsychological testing.
- •Screening laboratory tests without significant abnormalities that might interfere with the study.
排除标准
- •Diagnosis of probable Alzheimer's disease or any other dementia (e.g. vascular, Lewy body, frontotemporal)
- •Evidence of other neurological or physical illness that can produce cognitive deterioration. Determination of dementia will be based on the clinical evaluation including assessment of functional abilities, and cognitive screening (using the Mini Mental State Examination
- •Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale [38].
- •Uncontrolled hypertension (systolic blood pressure (BP) > 170 or diastolic BP > 100).
- •Consume spices regularly > 5g day
- •Allergy or sensitivity to spices. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive history of spices ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded.
- •Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
- •Current diagnosis or alcoholism or substance addiction.
- •Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
- •Frequently using prebiotics, probiotics, yogurt, and/or any fiber supplements
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Mixed spices
干预措施: Mixed spices (Dietary Supplement)
结局指标
主要结局
Memory
时间窗: 6 month
Verbal Episodic Memory (Rey Auditory Verbal Learning Test (RAVLT)-Revised, number of words correctly recalled after the long delay).
次要结局
- Executive Function(6 month)
- Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory(6 month)
- Fatigue(6 month)
- Body weight(6 month)
- Body composition(6 month)
- Sleep Quality(6 month)
- 24-hour Diet Recall(6 month)
- Quality of life, SF-36(6 month)
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