The Chronic Cognitive Effects of 6- and 12-weeks Administration of a Food Supplement Containing Phosphatidylserine: A Double Blind, Randomized, Placebo Controlled, Parallel Groups Study in Healthy Children Aged 8 to 12 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- COMPASS global performance measures
研究概览
简要总结
The purpose of this study is to assess the cognitive effects (attention, learning, and memory) of 6 and 12 weeks administration of a supplement containing phosphatidylserine in comparison to a placebo in healthy children aged 8 to 12 years old. The study will utilize Rey Auditory Verbal Learning Test (RAVLT) and Computerised Mental Performance Assessment System (COMPASS, Northumbria University) for a broad assessment of cognitive function/learning, and actigraphy to monitor sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be in good health as reported by themselves and their parent/guardian.
- •Healthy children aged 8 to 12 years and enrolled in school years 4 to 7 at the time of giving consent
- •Have been speaking English at school since reception
- •Willingness of the children and parents to give their written informed consent, according to GCP and local regulations and being able to participate in all scheduled visits, intervention plans, tests and other trial procedures
- •Children with a normal sex and age-related BMI according to the local NHS guidelines (3rd to 90th percentiles)
排除标准
- •Relevant allergy or known hypersensitivity to one of the ingredients contained in the investigational drug.
- •Are currently taking any illicit, herbal or recreational drugs including alcohol and tobacco.
- •Taking any prescribed or OTC medication against chronic or non- chronic illnesses.
- •Have used dietary supplements within the last 4 weeks
- •Are diagnosed with ADHD, dyslexia or any neurodevelopmental disorder or learning difficulty.
- •Suffer from visual (including colour blindness) or hearing impairment (that may impact task performance in the opinion of the PI.
- •Have any serious illness, cognitive impairment or medical disorder that may confound with study results or interfere with compliance.
- •Have any other active or unstable medical condition, that, in the opinion of the PI, may adversely affect the participant's ability to complete the study
- •Are experiencing exceptional social/family stressors.
- •Consume more than one portion (>100g) per week of the following dietary sources high in phosphatidylserine: Oily fish such as salmon, mackerel, herring, tuna and eel. Animal internal organs such as liver, kidney, brain and heart. Note: Information on continued adherence to this criteria will be captured within treatment diary. If a child continuously consumes more than one portion per week of PS rich food the sponsor will be informed on a case by case basis. If deemed to be significant, they will be excluded, (but allowed to continue the study to the end (day 84)) and will be replaced.
- •Subjects that have followed specific diet, e.g. high protein diet, within 30 days prior to study start
- •Serious diet change, e.g. Ketogenic or vegan, within 30 days prior to study start.
- •Consumption of > 250 mg/day of caffeine.
- •Are unable to complete all of the study assessments
- •Are currently participating in other clinical or nutrition intervention studies, or have in the past 8 weeks
- •Are non-compliant with regards treatment consumption
结局指标
主要结局
COMPASS global performance measures
时间窗: Following 12 weeks of intervention
Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Cognitive domain factor score
时间窗: Following 12 weeks of intervention
Speed of attention, accuracy of attention, speed of memory, accuracy of working memory, and accuracy of episodic memory measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Location Learning score
时间窗: Following 12 weeks of intervention
Learning index, displacement score, and delayed recall score, measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Rey Auditory Verbal Learning Test (RAVLT)
时间窗: Following 12 weeks of intervention
Learning score, Immediate recall, delayed recall, and delayed recognition measured by the Rey Auditory Verbal Learning Test
次要结局
- Parent Visual Analogue Scales (VAS)(Following 6 and 12 weeks of intervention)
- Rey Auditory Verbal Learning Test (RAVLT)(Following 6 weeks of intervention)
- Children's Sleep Habits Questionnaire (CSHQ)(Following 6 and 12 weeks of intervention)
- Sleep measures(Following 12 weeks of intervention)
- Cognitive domain factor score(Following 6 weeks of intervention)
- Individual cognitive task score(Following 6 and 12 weeks of intervention)
- COMPASS global performance measures(Following 6 weeks of intervention)
- Children's Sleep self-report (SSR) questionnaire(Following 6 and 12 weeks of intervention)
- Location Learning score(Following 6 weeks of intervention)
- Child mood Visual Analogue Scales (VAS)(Following 6 and 12 weeks of intervention)
研究者
Philippa Jackson
Principal Investigator
Northumbria University