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

A Double Blind, Randomized, Controlled Study for the Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience

The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation

Study Overview

• Status: Completed
• Conditions: Smoking Reduction
• Intervention / Treatment: Dietary supplement: Experimental product consumption; Other: Control product consumption

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Avena Sativa L. consumption of 900 mg for 60 days.	Dietary supplement: Experimental product consumption; Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days
Placebo Comparator: Control group; Identically appearing placebo capsules consumed for 60 days.	Other: Control product consumption; Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wellbeing / wellness	WHOQOL BREF test	From baseline to 8 weeks later

Secondary Outcome Measures

Outcome Measure	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
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).

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Wellbeing; Wellness
• Other Study ID Numbers: UCAMCFE-00018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No