Smoking CessationNCT04618705
Gut Microbiome and Weight Gain After Smoking Cessation
A study testing Smoking Cessation in people with Smoking Cessation and Weight Gain, run by Eran Elinav.
Trial summary
Investigating the effect of smoking and smoking cessation on the intestinal microbial composition and function. The investigators wish to determine whether the alteration in gut microbiome drives the significant weight gain seen in humans after smoking cessation, and find the mechanism by which the gut microbiome… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Weight Gain
- What is being tested?
- Smoking Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to Sep 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smokers for at least 10 years, hereinafter 'control group'.
- Cigarette smokers for at least 2 years, 5 or more cigarettes per day, that do not plan to quit hereinafter 'smoking group'.
- Cigarette smokers for at least 2 years, 5 or more cigarettes per day, who plan to quit smoking hereinafter 'cessation group'.
- Age - 18-70
- BMI<28
- Capable of working with the smartphone application in Hebrew or English.
Who cannot join
- Consumption of antibiotics/oral antifungals/ probiotics 3 months before the first day of the experiment.
- Constant consumption of drugs (cannabis etc..) in the last 2 years
- Pregnancy in the last 6 months, breastfeeding, and active fertility treatments within the past year
- Diagnosis of type 1 or type 2 diabetes
- Chronic disease (infectious, autoimmune, endocrine, metabolic, neurodegenerative)
- Cancer and recent anticancer treatment within the last 5 years
Show all 12Show fewer
- Neuro-psychiatric disorders
- Coagulation disorders
- Inflammatory bowel diseases (IBD)
- Bariatric surgery within the last 5 years
- BMI>28
- Alcohol or substance abuse
About this study
Official title: The Role of the Gut Microbiome in Post-smoking Weight Gain
Investigating the effect of smoking and smoking cessation on the intestinal microbial composition and function. The investigators wish to determine whether the alteration in gut microbiome drives the significant weight gain seen in humans after smoking cessation, and find the mechanism by which the gut microbiome contributes to this phenomenon.
Read the detailed description
Cigarette smoking causes a variety of health problems, including cardiovascular disorders, cancer, pulmonary diseases, autoimmune diseases, premature birth, and certain birth defects. Health benefits of smoking cessation start very fast after the last smoke. However, smoking cessation has significant side effects including weight gain. Several theories have been proposed to explain weight gain after smoking cessation.
Microbiome research is an upcoming, extensively followed research field that has found unsuspected connections between human health and gut occupants. Many recent studies established important roles for the gut microbiome in regulating obesity, and metabolic diseases.
The general aim of this study is to investigate the effect of smoking and smoking cessation on the intestinal microbial composition and function.
This study follows 200 healthy participants who will be recruited according to their affiliation to one of three groups:
Group 1: Non-smokers for at least 10 years Group 2: Cigarette smokers that do not plan to quit. Group 3: Cigarette smokers who plan to quit smoking. Participants who are planning to quit cigarette smoking will be offered to join a program for smoking cessation. The study will start 8 days before cessation group volunteers will stop smoking and will continue for one year after. Participants of all groups will be followed-up for one year.
During the study, the participants will collect stool and oral samples which will be used for microbiota profiling. At every meeting anthropometric measurements, blood samples will be taken, and body composition performed. Participants will be connected to a continuous glucose monitor and will be asked to log a food diary using a designated mobile phone application.
- Conditions
- Smoking Cessation, Weight Gain
- Being tested
- Smoking Cessation
- Keywords
- Smoking cessation, Microbiome, Weight gain
- Medical subject headings
- Smoking Cessation, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking CessationBehavioural
Participants will start a smoking cessation program.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Participants who have not smoked for at least 10 years |
| smoking group | No intervention | Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years. |
| smoking cessation group | Experimental | Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years and who are planning to quit smoking. Receives: Behavioral: Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome composition
Stool and oral samples
Measured: 1 year
Secondary outcomes (2)
Weight changes from baseline
Weight (Kg)
Measured: 1 year
Blood glucose responses
Continuous glucose monitoring (CGM),
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 May 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: priority reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel non-randomized study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eran Elinav
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eran Elinav, Weizmann Institute of Science
- Investigators
- Eran Elinav, Prof, Principal investigator, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618705
- Sponsor's protocol ID
- 1093-1
- Status last verified
- Feb 2023
- First submitted
- 21 Oct 2020
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/
PubMed 24455788Benowitz NL. Cigarette smoking and cardiovascular disease: pathophysiology and implications for treatment. Prog Cardiovasc Dis. 2003 Jul-Aug;46(1):91-111. doi: 10.1016/s0033-0620(03)00087-2. No abstract available.
PubMed 12920702Grando SA. Connections of nicotine to cancer. Nat Rev Cancer. 2014 Jun;14(6):419-29. doi: 10.1038/nrc3725. Epub 2014 May 15.
PubMed 24827506Grumelli S, Corry DB, Song LZ, Song L, Green L, Huh J, Hacken J, Espada R, Bag R, Lewis DE, Kheradmand F. An immune basis for lung parenchymal destruction in chronic obstructive pulmonary disease and emphysema. PLoS Med. 2004 Oct;1(1):e8. doi: 10.1371/journal.pmed.0010008. Epub 2004 Oct 19.
PubMed 15526056Costenbader KH, Karlson EW. Cigarette smoking and autoimmune disease: what can we learn from epidemiology? Lupus. 2006;15(11):737-45. doi: 10.1177/0961203306069344.
PubMed 17153844Dahlin S, Gunnerbeck A, Wikstrom AK, Cnattingius S, Edstedt Bonamy AK. Maternal tobacco use and extremely premature birth - a population-based cohort study. BJOG. 2016 Nov;123(12):1938-1946. doi: 10.1111/1471-0528.14213. Epub 2016 Jul 14.
PubMed 27411948Hackshaw A, Rodeck C, Boniface S. Maternal smoking in pregnancy and birth defects: a systematic review based on 173 687 malformed cases and 11.7 million controls. Hum Reprod Update. 2011 Sep-Oct;17(5):589-604. doi: 10.1093/humupd/dmr022. Epub 2011 Jul 11.
PubMed 21747128Harris KK, Zopey M, Friedman TC. Metabolic effects of smoking cessation. Nat Rev Endocrinol. 2016 Nov;12(11):684. doi: 10.1038/nrendo.2016.171. Epub 2016 Sep 30. No abstract available.
PubMed 27688045Martinez de Morentin PB, Whittle AJ, Ferno J, Nogueiras R, Dieguez C, Vidal-Puig A, Lopez M. Nicotine induces negative energy balance through hypothalamic AMP-activated protein kinase. Diabetes. 2012 Apr;61(4):807-17. doi: 10.2337/db11-1079. Epub 2012 Feb 7.
PubMed 22315316Chen H, Hansen MJ, Jones JE, Vlahos R, Anderson GP, Morris MJ. Long-term cigarette smoke exposure increases uncoupling protein expression but reduces energy intake. Brain Res. 2008 Sep 4;1228:81-8. doi: 10.1016/j.brainres.2008.06.067. Epub 2008 Jun 26.
PubMed 18619427Ussar S, Griffin NW, Bezy O, Fujisaka S, Vienberg S, Softic S, Deng L, Bry L, Gordon JI, Kahn CR. Interactions between Gut Microbiota, Host Genetics and Diet Modulate the Predisposition to Obesity and Metabolic Syndrome. Cell Metab. 2015 Sep 1;22(3):516-530. doi: 10.1016/j.cmet.2015.07.007. Epub 2015 Aug 20.
PubMed 26299453Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.
PubMed 17183312Hur KY, Lee MS. Gut Microbiota and Metabolic Disorders. Diabetes Metab J. 2015 Jun;39(3):198-203. doi: 10.4093/dmj.2015.39.3.198.
PubMed 26124989
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Gut Microbiome in Post-smoking Weight Gain
- ClinicalTrials.gov ID
- NCT04618705
- Acronym / sponsor ID
- 1093-1
- Conditions
- Smoking Cessation, Weight Gain
- Keywords
- Smoking cessation, Microbiome, Weight gain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: priority reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eran ElinavUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 6 Nov 2020 (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.
Investigating the effect of smoking and smoking cessation on the intestinal microbial composition and function. The investigators wish to determine whether the alteration in gut microbiome drives the significant weight gain seen in humans after smoking cessation, and find the mechanism by which the gut microbiome contributes to this phenomenon.
Detailed description
Cigarette smoking causes a variety of health problems, including cardiovascular disorders, cancer, pulmonary diseases, autoimmune diseases, premature birth, and certain birth defects. Health benefits of smoking cessation start very fast after the last smoke. However, smoking cessation has significant side effects including weight gain. Several theories have been proposed to explain weight gain after smoking cessation.
Microbiome research is an upcoming, extensively followed research field that has found unsuspected connections between human health and gut occupants. Many recent studies established important roles for the gut microbiome in regulating obesity, and metabolic diseases.
The general aim of this study is to investigate the effect of smoking and smoking cessation on the intestinal microbial composition and function.
This study follows 200 healthy participants who will be recruited according to their affiliation to one of three groups:
Group 1: Non-smokers for at least 10 years Group 2: Cigarette smokers that do not plan to quit. Group 3: Cigarette smokers who plan to quit smoking. Participants who are planning to quit cigarette smoking will be offered to join a program for smoking cessation. The study will start 8 days before cessation group volunteers will stop smoking and will continue for one year after. Participants of all groups will be followed-up for one year.
During the study, the participants will collect stool and oral samples which will be used for microbiota profiling. At every meeting anthropometric measurements, blood samples will be taken, and body composition performed. Participants will be connected to a continuous glucose monitor and will be asked to log a food diary using a designated mobile phone application.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel non-randomized study.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Participants who have not smoked for at least 10 years |
| smoking group | No intervention | –Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years. |
| smoking cessation group | Experimental | Behavioral: Smoking CessationParticipants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years and who are planning to quit smoking. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-smokers for at least 10 years, hereinafter 'control group'.
- Cigarette smokers for at least 2 years, 5 or more cigarettes per day, that do not plan to quit hereinafter 'smoking group'.
- Cigarette smokers for at least 2 years, 5 or more cigarettes per day, who plan to quit smoking hereinafter 'cessation group'.
- Age - 18-70
- BMI<28
Key exclusion criteria (12 listed)
- Consumption of antibiotics/oral antifungals/ probiotics 3 months before the first day of the experiment.
- Constant consumption of drugs (cannabis etc..) in the last 2 years
- Pregnancy in the last 6 months, breastfeeding, and active fertility treatments within the past year
- Diagnosis of type 1 or type 2 diabetes
- Chronic disease (infectious, autoimmune, endocrine, metabolic, neurodegenerative)
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 |
|---|---|---|
| Smoking CessationParticipants will start a smoking cessation program. | Behavioural | smoking cessation group |
Primary outcome
Microbiome composition
Time frame: 1 year
Stool and oral samples
2 secondary outcomes
Weight changes from baseline
Time frame: 1 year
Blood glucose responses
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Results publication: PubMed 24455788National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/
- Results publication: PubMed 12920702Benowitz NL. Cigarette smoking and cardiovascular disease: pathophysiology and implications for treatment. Prog Cardiovasc Dis. 2003 Jul-Aug;46(1):91-111. doi: 10.1016/s0033-0620(03)00087-2. No abstract available.
- Results publication: PubMed 24827506Grando SA. Connections of nicotine to cancer. Nat Rev Cancer. 2014 Jun;14(6):419-29. doi: 10.1038/nrc3725. Epub 2014 May 15.
- Results publication: PubMed 15526056Grumelli S, Corry DB, Song LZ, Song L, Green L, Huh J, Hacken J, Espada R, Bag R, Lewis DE, Kheradmand F. An immune basis for lung parenchymal destruction in chronic obstructive pulmonary disease and emphysema. PLoS Med. 2004 Oct;1(1):e8. doi: 10.1371/journal.pmed.0010008. Epub 2004 Oct 19.
- Results publication: PubMed 17153844Costenbader KH, Karlson EW. Cigarette smoking and autoimmune disease: what can we learn from epidemiology? Lupus. 2006;15(11):737-45. doi: 10.1177/0961203306069344.
- Results publication: PubMed 27411948Dahlin S, Gunnerbeck A, Wikstrom AK, Cnattingius S, Edstedt Bonamy AK. Maternal tobacco use and extremely premature birth - a population-based cohort study. BJOG. 2016 Nov;123(12):1938-1946. doi: 10.1111/1471-0528.14213. Epub 2016 Jul 14.
- Results publication: PubMed 21747128Hackshaw A, Rodeck C, Boniface S. Maternal smoking in pregnancy and birth defects: a systematic review based on 173 687 malformed cases and 11.7 million controls. Hum Reprod Update. 2011 Sep-Oct;17(5):589-604. doi: 10.1093/humupd/dmr022. Epub 2011 Jul 11.
- Results publication: PubMed 27688045Harris KK, Zopey M, Friedman TC. Metabolic effects of smoking cessation. Nat Rev Endocrinol. 2016 Nov;12(11):684. doi: 10.1038/nrendo.2016.171. Epub 2016 Sep 30. No abstract available.
- Results publication: PubMed 22315316Martinez de Morentin PB, Whittle AJ, Ferno J, Nogueiras R, Dieguez C, Vidal-Puig A, Lopez M. Nicotine induces negative energy balance through hypothalamic AMP-activated protein kinase. Diabetes. 2012 Apr;61(4):807-17. doi: 10.2337/db11-1079. Epub 2012 Feb 7.
- Results publication: PubMed 18619427Chen H, Hansen MJ, Jones JE, Vlahos R, Anderson GP, Morris MJ. Long-term cigarette smoke exposure increases uncoupling protein expression but reduces energy intake. Brain Res. 2008 Sep 4;1228:81-8. doi: 10.1016/j.brainres.2008.06.067. Epub 2008 Jun 26.
- Results publication: PubMed 26299453Ussar S, Griffin NW, Bezy O, Fujisaka S, Vienberg S, Softic S, Deng L, Bry L, Gordon JI, Kahn CR. Interactions between Gut Microbiota, Host Genetics and Diet Modulate the Predisposition to Obesity and Metabolic Syndrome. Cell Metab. 2015 Sep 1;22(3):516-530. doi: 10.1016/j.cmet.2015.07.007. Epub 2015 Aug 20.
- Results publication: PubMed 17183312Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.
- Individual participant dataSharing planned: No
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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.
Eran Elinav, Prof principal investigator
Weizmann Institute of Science
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation in people with Smoking Cessation and Weight Gain, run by Eran Elinav.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Microbiome composition (time frame: 1 year). 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 NCT04618705, which also lists 13 linked publications.
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 14 Jul 2023.