ACUTE AND CHRONIC EFFECTS OF A PROPRIETARY BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL SECRETION AND METABOLISM IN HEALTHY ADULTS: RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Activ'inside
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Mood state
研究概览
简要总结
Mood disorders, including depression and anxiety, are one of the main causes of the overall disease burden worldwide.
In recent years, the efficacy of certain botanicals as an alternative solution for depression has been evaluated in a number of clinical trials.
However, only few studies looked at the effects of these botanicals on mood in healthy subjects.
The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups methodology is to assess the acute and chronic effects of daily supplementation with a proprietary and standardized botanical extract in comparison to placebo in healthy adults aged 18-60 years with self-reported low mood.
详细描述
The chronic effect of the active product on mood, anxiety, perceived stress, quality of life and cortisol secretion & metabolism will be assessed through validated questionnaires and urine collection after 2, 4 and 8 weeks of daily supplementation.
The acute effect of the product will be assessed after a single dose and exposure to an acute psychological stressor. Before, during and after the stressor, saliva samples will be collected and subjective levels of anxiety and mood will be measured. In addition, Galvanic Skin Response (GSR) and heart rate (HR) will be measured throughout the stressor session.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •With non-pathological feelings of anxiety and/ or stress in daily life:
- •Subjects self-reporting low mood;
- •Total score ≥ 40 at the Profile of Mood State (POMS 2);
- •Score < 16 at the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire
- •Score ≤ 10 at the Patient Health Questionnaire 9-item (PHQ-9)
- •Not meeting the diagnosis criteria for any mental disorder
- •Body Mass Index (BMI) in the normal range: 18.5 ≥ BMI ≤ 30 kg/ m2
- •For non-menopausal women: using effective contraception/pregnancy is not physiologically possible.
- •Subject showing no difficulty for salivary sampling
- •Subjects capable of and willing to comply with the protocol and to give their written informed consent
排除标准
- •Diagnosis of psychological pathology within the previous 3 years
- •Diagnosis of cognitive pathology
- •Anxiolytic or antidepressant treatment, within the previous 3 months
- •Event likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks or planned during the next 8 weeks
- •Menopausal transition
- •High blood pressure
- •Subjects diagnosed with diabetes, cardiovascular disease, recurrent infectious diseases or chronic inflammatory pathology
- •Usual corticoid treatment/ steroidal anti-inflammatory treatment
- •Unbalanced thyroid disease
- •High physical activity practice
- •Tobacco consumption
- •Subjects consuming any food supplement
- •Excessive alcohol or caffeine use
- •Consumption of recreational drugs
- •Subject currently participating in other clinical or nutrition intervention studies, or has done in the past 4 weeks.
研究组 & 干预措施
Active group
Proprietary, standardized botanical extract
干预措施: Proprietary, standardized botanical extract (Dietary Supplement)
Placebo group
Placebo (maltodextrin)
干预措施: Placebo (maltodextrin) (Dietary Supplement)
结局指标
主要结局
Mood state
时间窗: Week 8
Variation of the Profile of mood states (POMS-2) total score: TMD (Total Mood Disturbance score). The POMS-2 is a scale which includes six mood subscales: Anger, Confusion, Depression, Fatigue, Tension, and Vigor. Each subscale is scored between 0 and 100. TMD is determined by summing the Negative Mood State subscores and subtracting the Vigor subscore (unique Positive Mood State subscale). For each subscale except Vigor, a lower subscore indicates a better mood state. For the Vigor subscale, a higher subscore indicates a better mood state. A lower POMS-2 TMD indicates a better mood state.
次要结局
- Anxiety state State-Trait Anxiety Inventory(week 2, week 4, week 8)
- Quality of life score(week 2, week 4, week 8)
- Psychological response to an acute stressor assessed through the STAI(week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor)
- Coping response to stress(week 2, week 4, week 8)
- Biological response to an acute stressor(week 2, week 4 & week 8; at 15, 30, 45, 60 & 75 min after exposure to the stressor)
- Hemodynamic response to an acute stressor(week 2, week 4 & week 8; 0 to 15 min after exposure to the stressor)
- Galvanic Skin Response to the acute stressor(week 2, week 4 & week 8)
- POMS-2 subscores(week 2, week 4, week 8)
- Anxiety state according to the Hospital Anxiety and Depression Scale(week 2, week 4, week 8)
- Percentage of responders(week 2, week 4, week 8)
- Psychological stress(week 2, week 4, week 8)
- Worry feeling(week 2, week 4, week 8)
- Depressive-like state(week 2, week 4, week 8)
- Diurnal cortisol metabolism(week 2, week 4, week 8)
- Diurnal cortisol secretion(week 2, week 4, week 8)
- Psychological response to an acute stressor assessed on a Visual Analogical Scale(week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor)
- Cognitive performances(week 2, week 4, week 8)