Survey on the Management of Occasional or Anticipatory Stress by Consumers of a Food Supplement Based on L-theanine, Passionflower and Rhodiola Extracts and Satisfaction With This Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Larena SAS
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Evolution of level of felt stress before and after product intake
研究概览
简要总结
Volunteers will fill out an initial questionnaire which will describe their current situation, their pathologies and current treatments, their medical history.
Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.
详细描述
Participants in the survey will come from a panel of volunteers. They will be contacted via an email proposing the survey accompanied by a selection questionnaire. Eligible volunteers will be called by the clinical investigation center to confirm their participation.
Volunteers will fill out an initial questionnaire which will describe their current situation (sex, age, family and professional situation, cigarette consumption), their pathologies and current treatments, their medical history (disorders related to sleep, stress, anxiety, burnout, depression or other mental disorders).
Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥ 18 years old)
- •PSS Questionnaire (Perceived Stress Scale) ≥ 14
- •Believing that they could be exposed to a stressful event in the next 2 months
排除标准
- •Pregnant or breastfeeding woman
- •Currently taking a treatment from the following list: antihypertensives, immunosuppressants, antidepressants/barbiturates, anxiolytics, vitamin K antagonists (warfarin, acenocoumarol, fluindione), miconazole, anticonvulsants (carbamazepine, phenobarbital, phenytoin, oxcarbazepine...) and/or anti -infectious (rifampicin, rifabutin, efavirenz, nevirapine, griseofulvin)
- •With diabetes, autoimmune disease or hypotension
- •Currently taking a medication or dietary supplement that may affect mood, stress, sleep or anxiety
- •Currently using products containing any of the following ingredients: hawthorn, ashwagandha (Withania somnifera), bacopa monnieri, black grass, holy basil (Ocimum sanctum), fig buds, CBD, Eleutherococcus, Eschscholtzia, ginseng, griffonia, hops, oil lavender essential oil, marjoram essential oil, lavender hydrolyzate, milk protein hydrolyzate (Lactium), inositol, magnesium, lemon balm, St. John's wort, angelica orange, passionflower, rhodiola, saffron, theanine, asparagus stalk, tryptophan, valerian
- •Having known allergies to the ingredients of the product (theanine, rhodiola, passionflower and lavender)
结局指标
主要结局
Evolution of level of felt stress before and after product intake
时间窗: Before and 20 minutes after product intake
Change in stress VAS (visual analogue scale), minimum = 0 and maximum = 10 higher score means a worse outcome
次要结局
- Percentage of stress enhancement responders(Before and 20 minutes after product intake)
- Evolution of level of felt stress(stress usually felt, just before product intake, 20 minutes after product intake and before midnight)
- Evolution of stress-related signs before and after product intake(Before and 20 minutes after product intake)
- Percentage of stress-related signs enhancement responders(Before and 20 minutes after product intake)
- EvaluatIon of the organoleptic properties(Before midnight)
- satisfaction felt by volunteers(Before midnight)
- Adverse events(Before midnight)