Gut Microbiome and Weight Gain After Smoking Cessation

July 12, 2023 updated by: Eran Elinav

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome composition
Time Frame: 1 year
Stool and oral samples
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight changes from baseline
Time Frame: 1 year
Weight (Kg)
1 year
Blood glucose responses
Time Frame: 1 year
Continuous glucose monitoring (CGM),
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eran Elinav

Investigators

  • Principal Investigator: Eran Elinav, Prof, Weizmann institute of science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2023

Primary Completion (Estimated)

June 1, 2023

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

November 1, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1093-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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