Gut Microbiome and Weight Gain After Smoking Cessation

• Sponsor: Eran Elinav (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04618705
• Collaborator: (none)
• Enrollment: 200
• Arms: 3
• Anticipated Duration (Months): 22

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation; Weight Gain	Behavioral: Smoking Cessation	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel non-randomized study.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
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Microbiome composition [1 year]

   Stool and oral samples

Secondary Outcome Measures

1. Weight changes from baseline [1 year]

   Weight (Kg)

2. Blood glucose responses [1 year]

   Continuous glucose monitoring (CGM),

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Eran Elinav

Investigators

• Principal Investigator: Eran Elinav, Prof, Weizmann Institute of Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Nov 6, 2020
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eran Elinav, Principal Investigator, Host-Microbiome Interaction Research Group, Weizmann Institute of Science: Smoking cessation; Microbiome; Weight gain
• Additional relevant MeSH terms: Body Weight; Weight Gain

Study Results

No Results Posted as of Jul 12, 2022