A Randomised, Double-blind, Parallel Groups, Placebo-controlled 6 Weeks Human Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Cognitive performance change from baseline
研究概览
简要总结
The study will explore the effects of a 6-week phospholipid drink intervention on the cognitive performance and physiological and subjective stress parameters of males following a repeated psychosocial/physical stressor.
详细描述
The study conforms to a randomised, double-blind, placebo controlled, parallel groups design examining cognitive performance and physiological/subjective stress responses after a psychosocial/physical stressor before and after a six week daily intake of an phospholipid containing drink vs. placebo.
The study will examine:
Cognitive performance following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue.
Physiological and subjective stress responses following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male ≥18 years old
- •Healthy (self-report health questionnaire)
- •BMI <30 kg/m²
- •Free from medication (prescribed and 'over-the-counter')
排除标准
- •Current psychological affective/mood disorders
- •Self-reported physical disorder/disease (significant cardiovascular, autoimmune, endocrine, gastrointestinal or neurological conditions, chronic pain, or sleep disorders)
- •High chronic stress
- •Recreational drug use (within the last month)
- •Night shift work
- •Hypertension (resting blood pressure exceeding 160/95 mmHg)
- •Skin conditions (e.g. eczema) on hands
- •Food allergies
- •Participation in a clinical study within a month prior to screening or during participation
- •Participation in any of our previous stress induction studies
研究组 & 干预措施
Phospholipid drink
Participants will consume a phospholipid drink daily for 6 weeks
干预措施: Phospholipid drink (Dietary Supplement)
Placebo milk drink
Participants will consume a placebo drink (no added phospholipids) daily for 6 weeks
干预措施: Placebo milk drink (Dietary Supplement)
结局指标
主要结局
Cognitive performance change from baseline
时间窗: Week 1 (baseline) and week 6
Performance on a cognitive test battery at baseline will be compared to performance at week 6
次要结局
- Salivary cortisol change from baseline(Week 1 (baseline) and week 6)
- Blood pressure (systolic/diastolic) change from baseline(Week 1 (baseline) and week 6)
- Heart rate change from baseline(Week 1 (baseline) and 6 weeks)
- Subjective stress change from baseline(Week 1 (baseline) and 6 weeks)
- Subjective mood change from baseline(Week 1 (baseline) and 6 weeks)
研究者
Prof Louise Dye
Professor
University of Leeds