The Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation

Detailed Description
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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.

Official Title
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A Double Blind, Randomized, Controlled Study for the Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience

Conditions
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Smoking Reduction

Intervention / Treatment
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* Dietary Supplement: Experimental product consumption
* Other: Control product consumption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Avena Sativa L. consumption of 900 mg for 60 days. | Dietary Supplement: Experimental product consumption<br>* Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days<br>|
| Placebo Comparator: Control group<br>Identically appearing placebo capsules consumed for 60 days. | Other: Control product consumption<br>* Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing / wellness | WHOQOL BREF test | From baseline to 8 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing / wellness | WHOQOL BREF test | Day 1, at 4 and 12 weeks later | 
| Cognitive performance | COMPASS cognitive test panel | Day 1, at 4, 8 and 12 weeks later | 
| Quality of life panel | Using a visual analog scale where 0=not good at all, 10=very good | 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 | SF-36 test health questionnaire | Day 1, at 4 and 8 weeks later | 
| Brief questionnaire of smoking urges | QSU-Brief/Tiffany test | Day 1, at 4 and 8 weeks later | 
| Depression | Beck depression. Test to measure the level of depression of the subjects | Day 1, at 4 and 8 weeks later | 
| Perceived stress scale | Scale Remor, 2001. Test to measure the level of stress of the subjects | Day 1, at 4 and 8 weeks later | 
| Anxiety questionnaire | Test STAI, to measure the level of anxiety of the subjects | Day 1, at 4 and 8 weeks later | 
| Biopyrrin | Measured in urine | Day 1, at 4 and 8 weeks later | 
| Cortisol | Measured in saliva | Day 1, at 4 and 8 weeks later | 
| Nicotine Dependence | Fagerstrom test (FTND) | Day 1, at 4 and 8 weeks later | 
| Minnesota Nicotine Withdrawal scale | Nicotine withdrawal scale | Day 1, at 4 and 8 weeks later | 
| Number of cigarettes per day | Cigarettes per day self-reported in the daily diary, validated by cotinine and exhaled carbon monoxide at every visit | 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 | Visual analog scale where 0=no desire to smoke, 10=strong desire to smoke | Day 1, at 4 and 8 weeks later | 
| VAS symptoms severity panel | Using a visual analog scale where 0=very low, 10=very high | Day 1, at 4, 8 and 12 weeks later. | 
| Sleep efficiency | Measured by accelerometry, with Actigraph wGT3X-BT | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wellbeing, Wellness