Smoking Reduction
Conditions
Keywords
Wellbeing, Wellness
Brief summary
The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTExperimental product consumption
Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days
Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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: 1. Normal blood profile at screening 2. Subject is in a good physical health as established by medical history, vital signs, self-declaration and physical examination 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wellbeing / wellness | From baseline to 8 weeks later | WHOQOL BREF test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Dependence | Day 1, at 4 and 8 weeks later | Fagerstrom test (FTND) |
| Minnesota Nicotine Withdrawal scale | Day 1, at 4 and 8 weeks later | Nicotine withdrawal scale |
| Depression | Day 1, at 4 and 8 weeks later | Beck depression. Test to measure the level of depression of the subjects |
| Perceived stress scale | Day 1, at 4 and 8 weeks later | Scale Remor, 2001. Test to measure the level of stress of the subjects |
| Anxiety questionnaire | Day 1, at 4 and 8 weeks later | Test STAI, to measure the level of anxiety of the subjects |
| Biopyrrin | Day 1, at 4 and 8 weeks later | Measured in urine |
| Wellbeing / wellness | Day 1, at 4 and 12 weeks later | WHOQOL BREF test |
| Cortisol | Day 1, at 4 and 8 weeks later | Measured in saliva |
| 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. | Using a visual analog scale where 0=not good at all, 10=very good |
| Quality of life questionnaire | Day 1, at 4 and 8 weeks later | SF-36 test health questionnaire |
| Brief questionnaire of smoking urges | Day 1, at 4 and 8 weeks later | QSU-Brief/Tiffany test |
| 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 | Cigarettes per day self-reported in the daily diary, validated by cotinine and exhaled carbon monoxide at every visit |
| Craving level quantification | Day 1, at 4 and 8 weeks later | Visual analog scale where 0=no desire to smoke, 10=strong desire to smoke |
| VAS symptoms severity panel | Day 1, at 4, 8 and 12 weeks later. | Using a visual analog scale where 0=very low, 10=very high |
| 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). | Measured by accelerometry, with Actigraph wGT3X-BT |
| Cognitive performance | Day 1, at 4, 8 and 12 weeks later | COMPASS cognitive test panel |
Countries
Spain
Outcome results
None listed