The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
140
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
Catholic University of Murcia
Murcia, Spain
Wellbeing / wellness
WHOQOL BREF test
Time frame: From baseline to 8 weeks later
Wellbeing / wellness
WHOQOL BREF test
Time frame: Day 1, at 4 and 12 weeks later
Cognitive performance
COMPASS cognitive test panel
Time frame: 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
Time frame: 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
Time frame: Day 1, at 4 and 8 weeks later
Brief questionnaire of smoking urges
QSU-Brief/Tiffany test
Time frame: Day 1, at 4 and 8 weeks later
Depression
Beck depression. Test to measure the level of depression of the subjects
Time frame: Day 1, at 4 and 8 weeks later
Perceived stress scale
Scale Remor, 2001. Test to measure the level of stress of the subjects
Time frame: Day 1, at 4 and 8 weeks later
Anxiety questionnaire
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Test STAI, to measure the level of anxiety of the subjects
Time frame: Day 1, at 4 and 8 weeks later
Biopyrrin
Measured in urine
Time frame: Day 1, at 4 and 8 weeks later
Cortisol
Measured in saliva
Time frame: Day 1, at 4 and 8 weeks later
Nicotine Dependence
Fagerstrom test (FTND)
Time frame: Day 1, at 4 and 8 weeks later
Minnesota Nicotine Withdrawal scale
Nicotine withdrawal scale
Time frame: 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
Time frame: 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
Time frame: Day 1, at 4 and 8 weeks later
VAS symptoms severity panel
Using a visual analog scale where 0=very low, 10=very high
Time frame: Day 1, at 4, 8 and 12 weeks later.
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
Time frame: 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).