Acute Post-prandial Cognitive Effects Following Brown Seaweed Extract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Cognitive performance
研究概览
简要总结
The current study will explore the impact of seaweed extract on cognitive function following a high-carbohydrate meal at a number of time-points post-consumption.
详细描述
The current randomised, placebo-controlled, double-blind, parallel groups study will examine the impact of a brown seaweed extract (InSea2) on cognitive function post-prandially in 60 healthy non-elderly adults who self-report post-meal drowsiness. Computerised measures of episodic memory, attention and subjective state will be completed at baseline and for 3 hours following lunch with either seaweed or placebo consumed 30 minutes prior to a carbohydrate-rich meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Report post-meal drowsiness
排除标准
- •Below 18 or above 65 years old at the time of giving consent
- •Do not report post-meal drowsiness
- •Any pre-existing medical condition/illness
- •History of/current head trauma
- •History of intestinal tract surgery
- •History of/current diagnosis of drug/alcohol abuse
- •Currently taking prescription medications (excluding the contraceptive pill)
- •Habitual use of dietary/herbal supplements
- •Learning difficulties, ADHD (attention deficit hyperactivity disorder), dyslexia
- •Frequent migraines that require medication more than once/month.
- •Visual impairment that cannot be corrected with glasses or contact lenses
- •Excessive use of caffeine (>500mg per day) from all dietary sources
- •Not a native English speaker
- •Food intolerances/sensitivities, including seafood/fish allergy
- •Pregnancy, seeking to become pregnant, or current lactation
- •BMI <18.5 or >30 kg/m2
- •Any health condition that would prevent fulfilment of the study requirements
- •Inability to complete all of the study assessments
研究组 & 干预措施
500mg brown seaweed powder
2 x 250mg capsules InSea2® (brown seaweed powder)
干预措施: 500mg brown seaweed powder (Dietary Supplement)
Placebo
2 x capsules microcrystalline cellulose (bulking agent) (0mg InSea2®)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Cognitive performance
时间窗: Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose
Immediate word recall, simple reaction time, digit vigilance and choice reaction time measured via the Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
次要结局
- Subjective state(Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose)
研究者
Crystal Haskell-Ramsay
Associate Professor
Northumbria University