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

Not Applicable

Completed

• Conditions: Smoking Reduction
• Interventions: Other: Control product consumption; Dietary Supplement: Experimental product consumption

• Registration Number: NCT04749017
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Study First Submitted: 2020-12-01
• Study Start: 2021-01-20
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Primary Completion: 2021-07-30
• Status Verified: 2021-10
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control product consumption	Identically appearing placebo capsules consumed for 60 days.
Experimental group	Experimental product consumption	Avena Sativa L. consumption of 900 mg for 60 days.

Primary Outcome Measures

Name	Time	Method
Wellbeing / wellness	From baseline to 8 weeks later	WHOQOL BREF test

Secondary Outcome Measures

Name	Time	Method
Wellbeing / wellness	Day 1, at 4 and 12 weeks later	WHOQOL BREF test
Cognitive performance	Day 1, at 4, 8 and 12 weeks later	COMPASS cognitive test panel
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
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
Cortisol	Day 1, at 4 and 8 weeks later	Measured in saliva
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
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

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain