Clinical trial NCT04749017: The Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience
Official title: A Double Blind, Randomized, Controlled Study for the Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Reduction
Keywords: Wellbeing
Wellness
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wellbeing / wellness
timeFrame: From baseline to 8 weeks later
Secondary outcomes:
measure: Wellbeing / wellness
timeFrame: Day 1, at 4 and 12 weeks later
measure: Cognitive performance
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Quality of life panel
timeFrame: 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.
measure: Quality of life questionnaire
timeFrame: Day 1, at 4 and 8 weeks later
measure: Brief questionnaire of smoking urges
timeFrame: Day 1, at 4 and 8 weeks later
measure: Depression
timeFrame: Day 1, at 4 and 8 weeks later
measure: Perceived stress scale
timeFrame: Day 1, at 4 and 8 weeks later
measure: Anxiety questionnaire
timeFrame: Day 1, at 4 and 8 weeks later
measure: Biopyrrin
timeFrame: Day 1, at 4 and 8 weeks later
measure: Cortisol
timeFrame: Day 1, at 4 and 8 weeks later
measure: Nicotine Dependence
timeFrame: Day 1, at 4 and 8 weeks later
measure: Minnesota Nicotine Withdrawal scale
timeFrame: Day 1, at 4 and 8 weeks later
measure: Number of cigarettes per day
timeFrame: 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
measure: Craving level quantification
timeFrame: Day 1, at 4 and 8 weeks later
measure: VAS symptoms severity panel
timeFrame: Day 1, at 4, 8 and 12 weeks later.
measure: Sleep efficiency
timeFrame: 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).
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: