NCT05759910已完成不适用
A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Microphyt
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in spatial Working Memory
研究概览
简要总结
The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline.
In a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks. Cognitive function battery will be realized after 4 and 12 weeks of supplementation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to give written informed consent and to consume the investigational product daily for the duration of the study.
- •Healthy males and females aged ≥ 55 and ≤ 75 years old.
- •Body-mass index between 18.5 and 35.0 kg/m2
- •Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).
- •Have age-associated memory impairment (AAMI) based on the following National Institute of Mental Health criteria, specified as scoring:
- •Absence of dementia as determined by a score of >24 on the Mini Mental State Examination (MMSE).
- •≤29 or ≤9 on the VPA I and II portions of the Wechsler Memory Scale IV, respectively
- •A score on the MAC-Q of ≥
- •Is in general good health, as determined by the investigator
- •Ability to comply and understand the cognitive function practice tests
- •Willing to maintain their habitual diet and exercise routines.
- •Willing to maintain consistent sleep duration the evening before study visits.
排除标准
- •Use of medications or supplements known to alter cognitive function within past 2 weeks
- •Abnormal clinical laboratory test that may affect study outcome.
- •History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurological disorders (including sleep disorders, head injuries, Alzheimer's disease, Parkinson's disease, stroke, inflammatory brain disease
- •History or presence of cancer, except nonmelanoma skin cancer
- •Uncontrolled hypertension/diabetes
- •History of depression within past 24 months or use of psychotropic medications within 1 month of screening
- •Planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study.
- •History within previous 12 months of alcohol or substance abuse.
- •History of heavy smoking (>1 pack/day) within past 3 months
研究组 & 干预措施
Placebo group
Placebo Comparator
4 capsules per day containing 275mg of Maltodextrin
干预措施: Placebo (Dietary Supplement)
BrainPhyt High dose
Experimental
4 capsules per day containing 275mg of BrainPhyt
干预措施: Brainphyt high dose (Dietary Supplement)
结局指标
主要结局
Change in spatial Working Memory
时间窗: From week 0 to week 12
Mean Span Score in Corsi Blocks module of the COMPASS
次要结局
- Change in executive function(From week 0 to week 4)
- Change in perceptual and cognitive skills(From week 0 to week 12)
- Change in spatial working memory(From week 0 to week 4)
- Sleep quality(From week 0 to week 4)
- Mood state(From week 0 to week 12)
- Stress level(From week 0 to week 12)
- Change in episodic memory(From week 0 to week 4)
- Change in attention and vigilance(From week 0 to week 4)
- Inflammation IL-6(from week 0 to week 4)
- Change in attention and vigilance(From week 0 to week 12)
- Change in executive function(From week 0 to week 12)
- Change in episodic memory(From week 0 to week 12)
- Change in perceptual and cognitive skills(From week 0 to week 4)
- Stress level(From week 0 to week 4)
- Sleep quality(From week 0 to week 12)
- Mood state(From week 0 to week 4)
- Inflammation IL-6(from week 0 to week 12)
研究者
研究点 (1)
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