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Withdrawn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
About this trial
This is an interventional basic science trial for Smoking Cessation focused on measuring Smoking cessation, Microbiome, Weight gain
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
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
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.
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Citation
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Gut Microbiome and Weight Gain After Smoking Cessation
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