NCT04749017

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 15, 2022

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

December 1, 2020

Last Update Submit

February 11, 2022

Conditions

Smoking Reduction

Keywords

WellbeingWellness

Outcome Measures

Primary Outcomes (1)

  • Wellbeing / wellness

    WHOQOL BREF test

    From baseline to 8 weeks later

Secondary Outcomes (16)

  • Wellbeing / wellness

    Day 1, at 4 and 12 weeks later

  • Cognitive performance

    Day 1, at 4, 8 and 12 weeks later

  • 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.

  • Quality of life questionnaire

    Day 1, at 4 and 8 weeks later

  • Brief questionnaire of smoking urges

    Day 1, at 4 and 8 weeks later

  • +11 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Avena Sativa L. consumption of 900 mg for 60 days.

Dietary Supplement: Experimental product consumption

Control group

PLACEBO COMPARATOR

Identically appearing placebo capsules consumed for 60 days.

Other: Control product consumption

Interventions

Experimental product consumptionDIETARY_SUPPLEMENT

Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days

Experimental group
Control product consumptionOTHER

Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Related Publications (1)

  • 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.

    PMID: 38962436DERIVED

MeSH Terms

Conditions

Smoking Reduction

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmoking

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2020

First Posted

February 10, 2021

Study Start

January 20, 2021

Primary Completion

July 30, 2021

Study Completion

December 31, 2021

Last Updated

February 15, 2022

Record last verified: 2021-10

Locations

ES(1)