NCT04749017已完成不适用
A Double Blind, Randomized, Controlled Study for the Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience
Universidad Católica San Antonio de Murcia1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年1月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Wellbeing / wellness
研究概览
简要总结
The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation
详细描述
The duration of the study will be 90 days (12 weeks). The consumption time will be set at 60 days (8 weeks), the remaining 30 days will be for follow up, the product will not be consumed. Each day of the study will be recorded in a diary by each subject.
Subjects are randomized based on the number of cigarettes and the Richmond test. In addition, subjects with a high score on the DASS-21 test items could not participate in the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (age: 18 - 65 YO)
- •Willingness to reduce/quit daily cigarettes (Richmond test)
- •Regular smokers: ≥10 CPD for the last 6 months (mean of ~16)
- •At least 6 months of smoking
- •Exhaled CO level≥10 ppm
- •Healthy adults:
- •Normal blood profile at screening
- •Subject is in a good physical health as established by medical history, vital signs, self-declaration and physical examination
- •Without depression/ anxiety or stress (based on a psychological evaluation and DASS21 questionnaire)
- •Able to participate fully in all aspects of the study and had understood and signed the informed consent
- •Negative drug test (THC, Amphetamines, Methamphetamines, Cocaine and Opioids)
- •For women: Negative pregnancy test
排除标准
- •Use of any mineral/vitamin/drug or other supplements during the past month prior to study
- •Participate in another clinical trial in the last 6 months
- •Using (past 30 days) other smoking cessation aids, for example treatments for tobacco dependence or an investigational drug
- •Smoke other nicotine-containing products such as hookah smokeless tobacco or electronic cigarettes
- •Allergic or intolerance to one of the ingredients of the investigated product
- •Diagnosed or treated for mental illness/ disorder in the past year
- •Recent history (past year) of alcohol or drug abuse or dependence
- •Reported any active/chronic disease (such as: Celiac disease/active peptic ulcer) or chronic medications (except Hyperlipidaemia or hypertension that are stable on medications)
- •Any other laboratory abnormality, medical condition or psychiatric disorder which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
- •Pregnant, lactating women or women that plan to get pregnant
研究组 & 干预措施
Experimental group
Experimental
Avena Sativa L. consumption of 900 mg for 60 days.
干预措施: Experimental product consumption (Dietary Supplement)
Control group
Placebo Comparator
Identically appearing placebo capsules consumed for 60 days.
干预措施: Control product consumption (Other)
结局指标
主要结局
Wellbeing / wellness
时间窗: From baseline to 8 weeks later
WHOQOL BREF test
次要结局
- Perceived stress scale(Day 1, at 4 and 8 weeks later)
- Anxiety questionnaire(Day 1, at 4 and 8 weeks later)
- Biopyrrin(Day 1, at 4 and 8 weeks later)
- Cortisol(Day 1, at 4 and 8 weeks later)
- Nicotine Dependence(Day 1, at 4 and 8 weeks later)
- Minnesota Nicotine Withdrawal scale(Day 1, at 4 and 8 weeks later)
- Number of cigarettes per day(Number of daily cigarettes is recorded on a daily basis in the diary from week 1 to week 12. Cotinine and exhaled carbon moxide are measured on day 1, at 4, 8 and 12 weeks later)
- Craving level quantification(Day 1, at 4 and 8 weeks later)
- VAS symptoms severity panel(Day 1, at 4, 8 and 12 weeks later.)
- Sleep efficiency(It will be measured during 3 weekdays and one weekend day, before starting with the consumption of the product and before the end of the consumption (60 days).)
- Depression(Day 1, at 4 and 8 weeks later)
- Wellbeing / wellness(Day 1, at 4 and 12 weeks later)
- Cognitive performance(Day 1, at 4, 8 and 12 weeks later)
- Quality of life panel(Day 1, at 4, 8 and 12 weeks later. They also have to fill it in at home, in a diary, on the 15th, 45th and 75th day.)
- Quality of life questionnaire(Day 1, at 4 and 8 weeks later)
- Brief questionnaire of smoking urges(Day 1, at 4 and 8 weeks later)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia
研究点 (1)
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