search
Back to results

Gut Microbiome and Weight Gain After Smoking Cessation

Primary Purpose

Smoking Cessation, Weight Gain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smoking Cessation
Sponsored by
Eran Elinav
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Smoking Cessation focused on measuring Smoking cessation, Microbiome, Weight gain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Non-smokers for at least 10 years, hereinafter 'control group'.
  2. Cigarette smokers for at least 2 years, 5 or more cigarettes per day, that do not plan to quit hereinafter 'smoking group'.
  3. Cigarette smokers for at least 2 years, 5 or more cigarettes per day, who plan to quit smoking hereinafter 'cessation group'.
  4. Age - 18-70
  5. BMI<28
  6. Capable of working with the smartphone application in Hebrew or English.

Exclusion Criteria:

  1. Consumption of antibiotics/oral antifungals/ probiotics 3 months before the first day of the experiment.
  2. Constant consumption of drugs (cannabis etc..) in the last 2 years
  3. Pregnancy in the last 6 months, breastfeeding, and active fertility treatments within the past year
  4. Diagnosis of type 1 or type 2 diabetes
  5. Chronic disease (infectious, autoimmune, endocrine, metabolic, neurodegenerative)
  6. Cancer and recent anticancer treatment within the last 5 years
  7. Neuro-psychiatric disorders
  8. Coagulation disorders
  9. Inflammatory bowel diseases (IBD)
  10. Bariatric surgery within the last 5 years
  11. BMI>28
  12. Alcohol or substance abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    No Intervention

    Experimental

    Arm Label

    control group

    smoking group

    smoking cessation group

    Arm Description

    Participants who have not smoked for at least 10 years

    Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years.

    Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years and who are planning to quit smoking.

    Outcomes

    Primary Outcome Measures

    Microbiome composition
    Stool and oral samples

    Secondary Outcome Measures

    Weight changes from baseline
    Weight (Kg)
    Blood glucose responses
    Continuous glucose monitoring (CGM),

    Full Information

    First Posted
    October 21, 2020
    Last Updated
    July 12, 2023
    Sponsor
    Eran Elinav
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04618705
    Brief Title
    Gut Microbiome and Weight Gain After Smoking Cessation
    Official Title
    The Role of the Gut Microbiome in Post-smoking Weight Gain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    priority reasons
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Eran Elinav

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking Cessation, Weight Gain
    Keywords
    Smoking cessation, Microbiome, Weight gain

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel non-randomized study.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Participants who have not smoked for at least 10 years
    Arm Title
    smoking group
    Arm Type
    No Intervention
    Arm Description
    Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years.
    Arm Title
    smoking cessation group
    Arm Type
    Experimental
    Arm Description
    Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years and who are planning to quit smoking.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Smoking Cessation
    Intervention Description
    Participants will start a smoking cessation program.
    Primary Outcome Measure Information:
    Title
    Microbiome composition
    Description
    Stool and oral samples
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Weight changes from baseline
    Description
    Weight (Kg)
    Time Frame
    1 year
    Title
    Blood glucose responses
    Description
    Continuous glucose monitoring (CGM),
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 Neuro-psychiatric disorders Coagulation disorders Inflammatory bowel diseases (IBD) Bariatric surgery within the last 5 years BMI>28 Alcohol or substance abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eran Elinav, Prof
    Organizational Affiliation
    Weizmann Institute of Science
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24455788
    Citation
    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/
    Results Reference
    result
    PubMed Identifier
    12920702
    Citation
    Benowitz 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 Reference
    result
    PubMed Identifier
    24827506
    Citation
    Grando SA. Connections of nicotine to cancer. Nat Rev Cancer. 2014 Jun;14(6):419-29. doi: 10.1038/nrc3725. Epub 2014 May 15.
    Results Reference
    result
    PubMed Identifier
    15526056
    Citation
    Grumelli 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 Reference
    result
    PubMed Identifier
    17153844
    Citation
    Costenbader 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 Reference
    result
    PubMed Identifier
    27411948
    Citation
    Dahlin 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 Reference
    result
    PubMed Identifier
    21747128
    Citation
    Hackshaw 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 Reference
    result
    PubMed Identifier
    27688045
    Citation
    Harris 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 Reference
    result
    PubMed Identifier
    22315316
    Citation
    Martinez 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 Reference
    result
    PubMed Identifier
    18619427
    Citation
    Chen 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 Reference
    result
    PubMed Identifier
    26299453
    Citation
    Ussar 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. Erratum In: Cell Metab. 2016 Mar 8;23(3):564-6.
    Results Reference
    result
    PubMed Identifier
    17183312
    Citation
    Turnbaugh 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.
    Results Reference
    result
    PubMed Identifier
    26124989
    Citation
    Hur 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.
    Results Reference
    result

    Learn more about this trial

    Gut Microbiome and Weight Gain After Smoking Cessation

    We'll reach out to this number within 24 hrs