NCT02439983已完成不适用
A Randomized, Double-blind, Placebo-controlled Study Investigating the Effects of a Proprietary Nutritional Supplement on Brain Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pharmanex
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in MRI Brain scan
研究概览
简要总结
The study is designed to evaluate the effects of the proprietary nutritional supplement on cognition, mood, and brain imaging parameters following a relatively short period of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both male and female subjects will be included.
- •Age between 40-60 years inclusive.
- •Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
- •Eats 1 or fewer servings of fatty fish per week.
- •BMI < 35
排除标准
- •Current or past neurological illness.
- •Substance abuse or dependence within the prior 60 days.
- •Current depression (HAMD greater than 20) or anxiety disorder (HAMA greater than 18).
- •Current or past history of psychiatric disorder.
- •History of head trauma with loss of consciousness.
- •Contraindication to brain MRI examination.
- •Supplementation with Omega 3, fish oil, or other over the counter supplements including the other bioactive ingredients in the proprietary nutritional supplement, antioxidants and multi-vitamin mineral supplements for the previous 3 months.
- •Plasma Omega3 Index >5% at screening visit.
- •Subject has a known allergy or intolerance to any of the ingredients contained in the proprietary nutritional supplement or placebo.
- •Subject is currently pregnant, planning to become pregnant, or is breastfeeding.
结局指标
主要结局
Change in MRI Brain scan
时间窗: Change from Baseline MRI Brain scan at Day 42
Determine differences in brain metabolism, brain connectivity, or brain structure. Highlight regional brain changes between pre and post chronic supplementation with a proprietary nutritional formula.
次要结局
- Change in mood as measured by the Profile of Mood States (POMS)(Change from Baseline mood at Day 42)
- Change in Chemistry panel(Change from Baseline Chemistry panel at Day 42)
- Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)(Change from Baseline depression at Day 42)
- Measurement of polyphenol metabolites in saliva(Day 42)
- Change in memory as measured by Logical Memory I and II (subtests from the Wechsler Memory Scale- IV)(Change from Baseline memory at Day 42)
- Change in fluency as measure by Letter and Category Fluency test(Change from Baseline fluency at Day 42)
- Change in RBC fatty acid profile(Change from Baseline RBC fatty acid profile at Day 42)
- Change in Gene expression(Change from Baseline Gene expression at Day 42)
- Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)(Change from Baseline anxiety at Day 42)
研究者
研究点 (2)
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