Smoking ReductionSMOKNCT04749017
The Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience
A study testing Experimental product consumption in people with Smoking Reduction, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing during smoking reduction/cessation Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Reduction
- What is being tested?
- Experimental product consumption
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- Normal blood profile at screening
- Subject is in a good physical health as established by medical history, vital signs, self-declaration and physical examination
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Smoking Reduction
- Being tested
- Experimental product consumption, Control product consumption
- Keywords
- Wellbeing, Wellness
- Medical subject headings
- Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental product consumptionDietary supplement
Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days
Control product consumptionOther
Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Avena Sativa L. consumption of 900 mg for 60 days. Receives: Dietary Supplement: Experimental product consumption |
| Control group | Placebo comparator | Identically appearing placebo capsules consumed for 60 days. Receives: Other: Control product consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellbeing / wellness
WHOQOL BREF test
Measured: From baseline to 8 weeks later
Secondary outcomes (16)
Wellbeing / wellness
WHOQOL BREF test
Measured: Day 1, at 4 and 12 weeks later
Cognitive performance
COMPASS cognitive test panel
Measured: 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
Measured: 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
Measured: Day 1, at 4 and 8 weeks later
Brief questionnaire of smoking urges
QSU-Brief/Tiffany test
Measured: Day 1, at 4 and 8 weeks later
Depression
Beck depression. Test to measure the level of depression of the subjects
Measured: Day 1, at 4 and 8 weeks later
Perceived stress scale
Scale Remor, 2001. Test to measure the level of stress of the subjects
Measured: Day 1, at 4 and 8 weeks later
Anxiety questionnaire
Test STAI, to measure the level of anxiety of the subjects
Measured: Day 1, at 4 and 8 weeks later
Biopyrrin
Measured in urine
Measured: Day 1, at 4 and 8 weeks later
Cortisol
Measured in saliva
Measured: Day 1, at 4 and 8 weeks later
Nicotine Dependence
Fagerstrom test (FTND)
Measured: Day 1, at 4 and 8 weeks later
Minnesota Nicotine Withdrawal scale
Nicotine withdrawal scale
Measured: 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
Measured: 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
Measured: Day 1, at 4 and 8 weeks later
VAS symptoms severity panel
Using a visual analog scale where 0=very low, 10=very high
Measured: Day 1, at 4, 8 and 12 weeks later.
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start20 Jan 2021
- Primary completion30 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749017
- Sponsor's protocol ID
- UCAMCFE-00018
- Acronym
- SMOK
- Status last verified
- Oct 2021
- First submitted
- 1 Dec 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38962436
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Controlled Study for the Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience
- ClinicalTrials.gov ID
- NCT04749017
- Acronym / sponsor ID
- SMOK / UCAMCFE-00018
- Conditions
- Smoking Reduction
- Keywords
- Wellbeing, Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Experimental product consumptionAvena Sativa L. consumption of 900 mg for 60 days. |
| Control group | Placebo comparator | Other: Control product consumptionIdentically appearing placebo capsules consumed for 60 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental product consumptionConsumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days | Dietary supplement | Experimental group |
| Control product consumptionConsumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening | Other | Control group |
Primary outcome
Wellbeing / wellness
Time frame: From baseline to 8 weeks later
WHOQOL BREF test
16 secondary outcomes
Wellbeing / wellness
Time frame: Day 1, at 4 and 12 weeks later
Cognitive performance
Time frame: Day 1, at 4, 8 and 12 weeks later
Quality of life panel
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
Time frame: Day 1, at 4 and 8 weeks later
Brief questionnaire of smoking urges
Time frame: Day 1, at 4 and 8 weeks later
Depression
Time frame: Day 1, at 4 and 8 weeks later
Perceived stress scale
Time frame: Day 1, at 4 and 8 weeks later
Anxiety questionnaire
Time frame: Day 1, at 4 and 8 weeks later
Biopyrrin
Time frame: Day 1, at 4 and 8 weeks later
Cortisol
Time frame: Day 1, at 4 and 8 weeks later
Nicotine Dependence
Time frame: Day 1, at 4 and 8 weeks later
Minnesota Nicotine Withdrawal scale
Time frame: Day 1, at 4 and 8 weeks later
Number of cigarettes per day
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
Time frame: Day 1, at 4 and 8 weeks later
VAS symptoms severity panel
Time frame: Day 1, at 4, 8 and 12 weeks later.
Sleep efficiency
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Derived from this study: PubMed 38962436Friling 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental product consumption in people with Smoking Reduction, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wellbeing / wellness (time frame: From baseline to 8 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04749017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.