Effects of a Plant Extract Modulating the Endocannabinoid System and Its Anxiolytic Capacity on Elderly People in Situations of Stress or Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in Hamilton Anxiety Rating Scale (HAM-A) score
研究概览
简要总结
The goal of this pilot clinical trial is to evaluate if one specific botanical extract from Grains of Paradise works to induce anxiolytic effect in adult people in stress or anxiety situations It will also learn about the extract's positive effects on sleep and mood. The main questions it aims to answer are:
Does botanical extract exert an anxiolytic effect on the participants under stress or anxiety circumstances? Does botanical extract promote positive effects on Mood and nocturnal sleep? Does botanical extract influence body parameters like Blood pressure, inflammatory indicators or stress hormones? Researchers will compare tree doses of botanical extract (50,100 or 150mg) to a placebo (a look-alike substance that contains no herbal product) to see if herbal extract support anxiolytic effect.
Participants will:
Take herbal extract or a placebo daily for 3 days. Visit the clinic two times: at the start of the study (day0) and to the end of the study (Day +2)for checkups and tests.
Keep a diary with questions about their activities, daily foods and physicals perceptions.
详细描述
The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the effects of standardized aframomum melegueta seed extract (AME) supplementation on anxiety, mood and sleep quality in healthy men and women experiencing anxious situations. A total of 37 participants were randomly assigned to either AME-first groups or placebo-first group; participants were taken 50, 100 or 150 mg of either AME or matched placebo peels daily for three days. This period is followed by a 1 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention. All Participants were instructed to follow a standardized training program throughout the study, including washout periods to maintain uniformity in physical activity and reduce the effect that exercise can have on stress management. The effects of supplement AME doses compared with a placebo, were evaluated using measures to assess anxiety [The Hamilton Anxiety Scale (HAM-A)], mood [Adapted Profile Mood State (POMS)], sleep quality [Sleep Evaluation Questionnaire (LSEQ) and Pittsburgh Sleep Quality Index (PSQI)]. In addition, some physiological (Blood pressure and heart rate variability), biochemical (minerals, hepatic enzymes and inflammatory biomarkers) and hematological variables (Complete cell count) were determined. Testing was completed at the beginning (Day0) and at the end (Day2) of the supplementation periods with the extract and placebo products to assess acute effects following 3 days of daily use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both the placebo (0 mg) and Botanical extract capsules (50mg, 100mg and 150mg) were identical in appearance to maintain the blindness of the study treatment. Only an unblinded research assistant will have knowledge of which label corresponds to Vanizem doses or placebo. That research assistant will be in charge of: (1) Before each appointment, distributing appropriate treatments or placebo pills into closable pots with a number corresponding to each participant. Care-providers will give closed pots to participants at the time of assessment. (2) Re-labeling all collected data and samples with a participant code number, and sorting into appropriate groups for analysis by blinded researchers.The investigators, study staff, subjects, and statisticians were blinded to the study.
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 40 and 50 year of age;
- •Healthy people with moderate anxiety: HAM-A score in a range between 18 and 24;
- •Subject able and willing to participate to the study by complying with the protocol procedures as confirmed by his dated and signed informed consent form;
排除标准
- •Score greater than 20 points on the Hamilton Depression Rating Scale (HDRS);
- •Receiving medical treatment for anxiety, stress or depression;
- •Drugs and alcohol dependence;
- •Serious personality disorders that may interfere with participation in the study (psychosis, intense suicidal ideation, etc.);
- •In the case of women, having the intention of becoming pregnant;
- •Epileptic disorders;
- •Liver disorders (cirrhosis, hepatitis, etc.);
- •Professional athletes or those who frequently engage in extreme physical activities;
- •Impossibility of completing the intervention period due to external factors;
结局指标
主要结局
Change in Hamilton Anxiety Rating Scale (HAM-A) score
时间窗: At baseline (day 0) and after intake period (day 2+)
Change in HAM-A score for Vanizem group compared to placebo control group. 14-items questionnaire reflecting 13 categories of anxiety-related symptom to measure anxiety.
次要结局
- Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score. 10-items evaluating four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness.(At baseline (day 0) and after intake period (day 1+ and day 2+))
- Change in blood minerals levels(At baseline (day 0) and after intake period (day 2+))
- Change in serum hepatic enzymes(At baseline (day 0) and after intake period (day 2+))
- Change in serum biomarker of stress(At baseline (day 0) and after intake period (day 2+))
- Change in Profile of Mood States (POMS) score(At baseline (day 0) and after intake period (day 2+))
- Change in blood pressure score(At baseline (day 0) and after intake period (day 2+))
- Change proinflammatory serum biomarkers(At baseline (day 0) and after intake period (day 2+))
- Change in blood cells count(At baseline (day 0) and after intake period (day 2+))
- Change in protein serum biomarker of inflammation(At baseline (day 0) and after intake period (day 2+))
- Change in Pittsburgh Sleep Quality Index (PSQI) score(At baseline (day 0) and after intake period (day 2+))
- Change in Heart Rate Variability (HRV)(At baseline (day 0) and after intake period (day 1+ and day 2+))
- Change in blood electrolyte levels(At baseline (day 0) and after intake period (day 2+))