NCT03909906已完成不适用
The Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress: a Randomised, Placebo-controlled, Double Blind Study in Healthy Humans
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Chronic treatment effects on anxiety following a psychological stressor
研究概览
简要总结
The aim of this study is to assess the chronic effects (14 days) of Euphytose® on psychological state, physiological stress responses and any resulting changes in gut microflora communities as compared to placebo.
详细描述
The aim of the proposed study is to assess the effects of chronic (14 days) supplementation with Euphytose® on psychological state with regards perceived stress and overall mood as well as psychological and physiological stress responses during a laboratory stressor. The trial will employ the Observed Multitasking Stressor (OMS), with psychological state and physiological responses assessed before and after its completion. The main mood/psychological stressor assessment will take place pre-treatment and following 14 days of treatment. Stool samples will also be collected from participants in order to assess changes in gut microflora communities at visits 1 and 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple masking (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
- •Aged 18-65 years
- •In good physical health
- •Subjects agree to abstain throughout the trial from all dietary supplements (note: protein shakes and garlic supplements are allowed)
- •Body Mass Index above 18 kg/m2 and below 35 kg/m2
- •Subjects are, in the opinion of the investigator, willing to participate in all scheduled visits and to adhere to all study procedures
- •Subjects accept to refrain from alcohol intake 24 hours prior to Testing Visits 1-4
- •Subjects do not have a current diagnosis of a significant medical condition which may interfere with the subject's ability to perform assessments and successfully completes training
- •Subjects provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial and understood and accepts these
- •Have a bank account (required for payment)
排除标准
- •Have any pre-existing medical condition/illness? NOTE: the exceptions to this are controlled (medicated) arthritis, asthma, high cholesterol and reflux-related conditions
- •Event (personal or professional) likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks (for example but not restricted to: change of professional function/situation, death of a family member, divorce, surgery, accident, etc.)
- •Event (personal or professional) likely to affect the subject's emotional, psychological or hormonal state planned during the next 8 weeks, including vaccination, important medical exam etc.
- •Smoking or the use of any nicotine replacement products e.g. vaping, gum, patches (smoking within the last 3 months)
- •Blood pressure >159/99 millimeters of mercury (mmHg)
- •Excessive use of caffeine (> 500 mg caffeine per day) from all dietary sources
- •Current intake of pharmaceuticals (excluding contraception and arthritis, cholesterol and reflux-related hormone replacement treatments (for female participants) where symptoms are stable and medications do not contraindicate the study outcomes and inhalers used as required)
- •Have taken antibiotics within the last 4 weeks
- •Any known active infections
- •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)
- •A history of neurological or psychiatric diseases excluding anxiety or depression
- •A diagnosis/treatment for a psychiatric disorder within the past 12 months (including anxiety or depression)
- •A history of significant head trauma
- •Have sleep disturbances and/or are taking sleep aid medication
- •Have learning difficulties or dyslexia
- •Have visual impairment that cannot be corrected with glasses or contact lenses (including colour blindness)
- •Have frequent migraines that require medication (more than or equal to 1 per month)
- •Not proficient in English equivalent to International English Language Testing System (IELTS) band 6 or above
- •Are pregnant, trying to get pregnant or breast feeding
- •Have any health condition that would prevent fulfillment of the study requirements
- •Any condition which may interfere with the subjects ability to perform assessments
- •Are employed in a job that includes night shift work
- •Have no access to the internet (including via smartphone)
- •Are unable to perform the computerized tests during training to the established acceptable levels for participation in this type of study.
- •Have habitually used supplements, within the last month (defined as more than 3 consecutive days or 4 days in total)
- •Participation in another clinical trial within 30 days prior to screening
- •Any history of hypersensitivity to the investigational product or its active or inactive constituents or any food allergy or intolerance
- •Non-compliant in terms of treatment consumption
研究组 & 干预措施
Euphytose®
Active Comparator
Euphytose® 2 tablets 3 times per day for 14 days
干预措施: Euphytose® (Drug)
Placebo
Placebo Comparator
Matched placebo 2 tablets, 3 times per day for 14 days
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Chronic treatment effects on anxiety following a psychological stressor
时间窗: Following 14 days treatment
Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - State subscale
次要结局
- Chronic (14 days) treatment effects on general psychological health(Following 14 days treatment)
- 7 days treatment effects on cognitive performance(Following 7 days treatment)
- Chronic (14 days) treatment effects on psychological distress(Following 14 days treatment)
- Chronic (14 days) treatment effects on subjective mood as assessed by visual analogue scales following a psychological stressor(Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor)
- Chronic (14 days) treatment effects on general anxiety(Following 14 days treatment)
- Chronic (14 days) treatment effects on subjective ratings of stress as assessed by visual analogue scales following a psychological stressor(Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor)
- Chronic (14 days) treatment effects on physiological stress responses(Measures taken following 14 days treatment prior to and during a psychological stressor)
- Chronic (14 days) treatment effects on gut microbiota(Following 14 days treatment)
- 13 days treatment effects on subjective ratings of mood as assessed by visual analogue scales(Following 13 days treatment)
- 13 days treatment effects on sedation(Following 13 days treatment)
- Chronic (14 Days) treatment effects on stress(Following 14 days treatment)
- Chronic (14 days) treatment effects on other physiological stress responses(Following 14 days treatment, measures taken at baseline, immediately before, after and then at 15, 30, 60 and 90 minutes following a psychological stressor)
- Chronic (14 days) treatment effects on cognitive performance during psychological stressor(Following 14 days treatment)
- 13 days treatment effects on subjective ratings of stress as assessed by visual analogue scales(Following 13 days treatment)
- 13 days treatment effects on stress(Following 13 days treatment)
- 7 days treatment effects on stress(Following 7 days treatment)
- 13 days treatment effects on cognitive performance(Following 13 days treatment)
- 7 days treatment effects on subjective ratings of mood as assessed by visual analogue scales(Following 7 days treatment)
- 7 days treatment effects on sedation(Following 7 days treatment)
- 7 days treatment effects on subjective ratings of stress as assessed by visual analogue scales(Following 7 days treatment)
研究者
Philippa Jackson
Senior Lecturer
Northumbria University
研究点 (1)
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