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Gut Microbiome and Weight Gain After Smoking Cessation

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ClinicalTrials.gov Identifier: NCT04618705
Recruitment Status : Not yet recruiting
First Posted : November 6, 2020
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Eran Elinav, Weizmann Institute of Science

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Weight Gain Behavioral: Smoking Cessation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel non-randomized study.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of the Gut Microbiome in Post-smoking Weight Gain
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: control group
Participants who have not smoked for at least 10 years
No Intervention: smoking group
Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years.
Experimental: smoking cessation group
Participants who have smoked cigarettes (at least 5 cigarettes per day) for at least 2 years and who are planning to quit smoking.
Behavioral: Smoking Cessation
Participants will start a smoking cessation program.




Primary Outcome Measures :
  1. Microbiome composition [ Time Frame: 1 year ]
    Stool and oral samples


Secondary Outcome Measures :
  1. Weight changes from baseline [ Time Frame: 1 year ]
    Weight (Kg)

  2. Blood glucose responses [ Time Frame: 1 year ]
    Continuous glucose monitoring (CGM),



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04618705


Contacts
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Contact: Alona Metz, Msc +97289529173 alona.metz@weizmann.ac.il
Contact: Aurelie Bukimer, Bsc +97289529173 aurelie.bukimer@weizmann.ac.il

Sponsors and Collaborators
Eran Elinav
Investigators
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Principal Investigator: Eran Elinav, Prof Weizmann Institute of Science
Publications of Results:

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Responsible Party: Eran Elinav, Principal Investigator, Host-Microbiome Interaction Research Group, Weizmann Institute of Science
ClinicalTrials.gov Identifier: NCT04618705    
Other Study ID Numbers: 1093-1
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eran Elinav, Weizmann Institute of Science:
Smoking cessation
Microbiome
Weight gain
Additional relevant MeSH terms:
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Body Weight
Weight Gain
Body Weight Changes