The Effect of Levagen+® Palmitoylethanolamide (PEA) Supplementation on Parameters of Stress, Wellbeing and Cognition in University Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- To assess the influence of PEA supplementation on Serum Brain-derived neurotrophic factor (BDNF) levels.
研究概览
简要总结
The goal of this randomised cross-over trial is to learn about the effects of Levagen+® Palmitoylethanolamide (PEA) supplementation on cognition, wellness and well-being in young and healthy university students.
The main question it aims to answer is:
• Does the PEA supplementation affect parameters of stress, mood, cognition and well-being in university students?
Participants will complete 2 baseline on-site visits during which they will be assigned to Levagen+® Palmitoylethanolamide (PEA) treatment or placebo arm each time and:
- complete anthropometric measurements, questionnaires and surveys,
- undergo blood and saliva sampling
- complete a cognitive assessment (CANTAB)
- a randomly chosen cohort will also measure heart rate variability (HRV) over 3 days.
Researchers will compare the PEA treatment group to the placebo to see if there is a significant difference.
详细描述
The study will investigate the effect of Levagen+® Palmitoylethanolamide (PEA) supplementation on parameters of stress, well-being and cognition at defined time points. Assessments will be made using a combination of a range of stress measures, which will include physiological and psychometric parameters.
Physiological measures will include assessments of known biomarkers of the principal stress-sensitive physiological systems, the hypothalamic-pituitary-adrenal axis, and the autonomic nervous system, while psychometric measures will include established instruments to assess general health, somatic stress symptoms, academic stress, response to stress, cognition, and mood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants (and supplements) will be coded and randomly allocated (applied randomly by software) to treatment arms to eliminate order effects and maintain research staff blinding.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males & Females
- •18 to 40 years of age
- •Fully enrolled full-time university students from London
排除标准
- •Consumption of >14 servings of alcohol/week
- •Any learning disability (e.g. dysphasia)
- •Any neurobiological disorders (e.g. autism)
- •Smokers Any allergies/health issues related to items being ingested
- •Any serious illnesses or those on chronic medication
- •Any pregnant or lactating women
- •Any woman who is trying to conceive
- •Any chronic gastrointestinal disorders
- •Any chronic menstrual disorders (e.g. PCOS)
- •Any subjects who have undergone menopause or undergoing the perimenopause transition
- •Any eating disorders
- •Any depression/mental disorders
- •Any obese sedentary (not physically active) individual, according to BMI values
- •Any abnormal blood pressure levels
- •Shift work
结局指标
主要结局
To assess the influence of PEA supplementation on Serum Brain-derived neurotrophic factor (BDNF) levels.
时间窗: The parameters were measured at the baseline visit (day 1) and at the endpoint visit (day 42) of the 6-week supplementation period.
Serum BDNF levels were measured.
To assess the influence of PEA supplementation on short-term and spatial working memory and problem solving.
时间窗: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
Spatial Working Memory (SWM) was used to measure short-term and spatial working memory and problem solving as part of the Core Cognition battery - CANTAB by Cambridge Cognition.
To assess the influence of PEA supplementation on visual processing, recognition, and sustained attention.
时间窗: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
Rapid Visual Information Processing (RVP) was used to assess visual processing, recognition, and sustained attention as part of the Core Cognition battery - CANTAB by Cambridge Cognition.
To assess the influence of PEA supplementation on the reaction and movement speed and attention.
时间窗: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
Reaction Time (RTI) was used to measure reaction and movement speed and attention as part of the Core Cognition battery - CANTAB by Cambridge Cognition.
To assess the influence of PEA supplementation on visual and episodic memory and visuospatial associative learning.
时间窗: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
Paired Associated Learning (PAL) was used to measure visual and episodic memory and visuospatial associative learning as part of the Core Cognition battery - CANTAB by Cambridge Cognition.
To assess the influence of PEA supplementation on the perceived difficulties of test execution.
时间窗: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
Motor Screening Task (MOT) was used as a screening tool to indicate difficulties in test execution as part of the Core Cognition battery - CANTAB by Cambridge Cognition.
次要结局
- To study the influence of PEA supplementation on well-being in females.(The parameters were measured for 3 continuous days following the baseline visit (day 1, day 2 and day 3) and for 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.)
- To study the influence of PEA supplementation on perceived emotions in females.(The parameters were measured for 3 continuous days following the baseline visit (day 1, day 2 and day 3) and for 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.)
- To assess the influence of PEA supplementation on parameters of inflammation.(The parameters were measured at the baseline visit (day 1) and at the endpoint visit (day 42) of the 6-week supplementation period.)
- To assess the influence of PEA supplementation on HRV in female population.(The parameters were measured for 3 continuous days following the baseline visit (day 1, day 2 and day 3) and for 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.)
- To study the influence of PEA supplementation on the degree of perceived stress in females.(The parameters were measured for 3 continuous days following the baseline visit (day 1, day 2 and day 3) and for 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.)
- To assess the influence of PEA supplementation on Salivary Cortisol(The parameters were measured in morning and afternoon samples collected over 3 continuous days following the baseline visit (day 1, day 2 and day 3) and 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.)
研究者
Mohammed Gulrez Zariwala
Professor in Translational Physiology
University of Westminster