Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mood
研究概览
简要总结
Hops have been used for many years for their supposed sedative and anxiety reducing properties and can be found in many natural remedies for stress, anxiety and sleeping that are already available to buy.
However, human trials investigating the effects of hops have so far been limited to the effects of the combination of hops and valerian in relation to sleep. Such studies have identified that a valerian-hops mixture can result in improved sleep but Valerian alone has no effect.
The current study aims to investigate the effect of hops alone in healthy human participants aged 18-35 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/female,
- •Age 18-35 years old
- •Non smoker
- •Proficient in English
- •Not taking any herbal or prescription medications
- •Not pregnant seeking to become pregnant or breastfeeding
排除标准
- •Allergy or hypersensitivity to any of the ingredients contained in the investigational product or any other foodstuff.
- •Vegetarian (as the capsules contain gelatine).
- •Have a history of neurological, vascular or psychiatric illness (including depressive illness and anxiety).
- •Have a current/ history of drug or alcohol abuse.
- •Currently take medication (excluding the contraceptive pill).
- •High Blood Pressure (>140/90)
- •BMI outside of the range 18- 34.9
结局指标
主要结局
Mood
时间窗: across 3 hours
* Mood as assessed by STAI, Bond-Lader mood scales, POMS, DEQ and stress/euphoria/sedation visual analogue scales (VAS). * The shift in mood (STAI, Bond-Lader, POMS, DEQ, Stress/Euphoria/Sedation VAS) inculcated by completion of cognitive tasks. * Heart rate and blood pressure. * The modulation of blood pressure and heart rate inculcated by completion of cognitive tasks.
次要结局
- Satiety(across 3 hours)
- Bioavailability of Hops(across 3 hours)
- Cognition(across 3 hours)
研究者
Crystal Haskell
Research Fellow
Northumbria University