Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in mood
研究概览
简要总结
The primary objectives of this study are to assess the effects of three investigational drinks containing three botanicals in differing combinations versus a placebo control, on mood, psychological state, physical response, and cognitive performance during and after exposure to an observed multi-tasking stressor.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 49 years
- •Self-report of good health
- •Are not excluded on the basis of the following exclusion criteria
排除标准
- •Are a smoker
- •Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
- •Currently take medication except the contraceptive pill
- •Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
- •Have sleep disturbances and/or are taking sleep aid medication Are employed in a job that includes night shift work
- •Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2or weigh less than 50kg or more than 85kg.
- •Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- •Have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety)
- •Have a history of anxiety or a current diagnosis of anxiety or depression
- •Are pregnant, trying to get pregnant or breast feeding
- •Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
- •Have learning difficulties or dyslexia
- •Have visual impairment that cannot be corrected with glasses or contact lenses
- •Have frequent migraines that require medication (more than or equal to 1 per month)
- •Have disorders of the blood (e.g. anaemia, hemophilia, thrombocytosis)
- •Have a heart disorder or a history of vascular illness
- •Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
- •Have a diagnosis of type I or type II diabetes
- •Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
- •Have any health condition that would prevent fulfillment of the study requirements
- •Are currently or have in the past 8weeks participated in other clinical or nutrition intervention studies
- •Have participated in the BPNRC's recent stress study
- •Do not have a bank account (required for payment)
研究组 & 干预措施
Control
Mix 1 flavored still beverage
干预措施: Herbal Beverage (Other)
Herbal beverage 1
Mix 2 flavored still beverage with a botanical extract(1)
干预措施: Herbal Beverage (Other)
Herbal Beverage 2
Mix 3 flavored still beverage with a botanical extract(2)
干预措施: Herbal Beverage (Other)
Combined Herbal Beverage
Mix 4 flavored still beverage with 2 botanical extracts (1,2)
干预措施: Herbal Beverage (Other)
结局指标
主要结局
Change in mood
时间窗: Pre dose, 60, 150, 240 min post dose
During each assessment mood and psychological state will be assessed before and after performance of an observed multi-tasking stressor via completion of the 'State' subscale of the State-Trait Anxiety Inventory and computerised versions of the Bond-Lader visual analogue mood scales and separate visual analogue scales (VAS) measuring subjective stress, relaxation and calmness.
次要结局
- Change in Cognitive function(Pre dose, 60, 150, 240 min post dose)