An Examination Into the Effects of a Nutraceutical Supplement on Cognition, Stress, and Eye and Skin Health in Adults With Self-reported Cognitive Complaints: a Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pharmanex
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in Working memory by Corsi Block tasks
研究概览
简要总结
This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.
详细描述
The objective of this prospective, placebo controlled, double-blinded, parallel-group study is to examine the effects of dietary supplement containing grape juice extract, astaxanthin, and vitamin E over 12 week consumption on cognitive performance and self report results based on questionnaires. Furthermore, an evaluation of general well-being, mood, markers of oxidative stress, neurogenesis (BDNF), eye health, skin health, skin carotenoid concentrations, and safety measurements will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Softgels with similar appearance
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health Individuals
- •Residing in independent living accommodations
- •Subjective report of memory or attention problems by answering 'yes' to the following questions: Do you have problems with your memory, attention, or concentration?
- •Non-smoker
- •Body Mass Index (BMI) between 18-35 kg/m2
- •No plan to commence new treatments over the study period
- •Understand, willing and able to comply with all study procedures
- •Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the study
排除标准
- •Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer's Association (NIA/AA) criteria
- •A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
- •Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/malignancy
- •Diagnosis of a psychiatric disease (other than mild-to moderate depression of anxiety) and/or neurological condition/disease (e.g. Parkinson's, Alzheimer's disease)
- •History of paralysis, stroke or seizures or head injury (with loss of consciousness)
- •Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibiters, or steroid medications.
- •Taking vitamins or herbal supplements that are reasonably expected to influence study measures
- •In the last 6 month, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcome
- •Alcohol intake greater than 14 standard drinks per week
- •Current or 12-month history of illicit drug abuse
- •Pregnant women, women who are Brest feeding, or women who intend to fall pregnant
- •Any significant surgeries over the last year
- •Planned major lifestyle change in the next 3 months
结局指标
主要结局
Change in Working memory by Corsi Block tasks
时间窗: Baseline and Week 12
Determine if working memory change by doing Corsi blocks task
Change in working memory
时间窗: Baseline and Week 12
Determine change in working memory as measured by the Numeric Working Memory Test
Change in verbal learning and memory
时间窗: Baseline and Week 12
Determine if verbal learning and memory change using total score on Rey Auditory Verbal Learning test trials 1 to 5
Change in episodic memory
时间窗: Baseline and Week 12
Determine change in episodic memory as measured by Rey Auditory Verbal Learning Test delayed recall and computerized location learning task
次要结局
- Change in marker of inflammation in the plasma(Baseline and Week 12)
- Change in accuracy of attention(Baseline and Week 12)
- Change in the Perceived Stress score(Baseline, Week 4, Week 8, Week 12)
- Change in Skin Carotenoid Score(Baseline and Week 12)
- Change in the Everyday Memory(Baseline, Week 4, Week 8, Week 12)
- Change in the World Health Organization score(Baseline, Week 4, Week 8, Week 12)
- Change in plasma Tumor Necrosis Factor-alpha concentrations(Baseline and Week 12)
- Change in plasma Brain-derived neurotropic factor concentrations(Baseline and Week 12)
- Change in oxidative stress marker(Baseline and Week 12)