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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Avena Sativa L. consumption of 900 mg for 60 days. |
|
| Control group | Placebo Comparator | Identically appearing placebo capsules consumed for 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental product consumption | Dietary Supplement | Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wellbeing / wellness | WHOQOL BREF test | From baseline to 8 weeks later |
| 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 |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38962436 | Derived | Friling M, Garcia-Munoz AM, Lavie A, Perez-Pinero S, Victoria-Montesinos D, Lopez-Roman FJ, Garcia-Guillen AI, Munoz-Carrillo JC, Canovas F, Ivanir E, Jalanka J. Dietary supplementation with a wild green oat extract (Avena sativa L.) to improve wellness and wellbeing during smoking reduction or cessation: a randomized double-blind controlled study. Front Nutr. 2024 Jun 19;11:1405156. doi: 10.3389/fnut.2024.1405156. eCollection 2024. |
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| ID | Term |
|---|---|
| D000074264 | Smoking Reduction |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
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| Control product consumption | Other | Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening |
|
| 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). |