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
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Weight Gain||Behavioral: Smoking Cessation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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|
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.
- Microbiome composition [ Time Frame: 1 year ]Stool and oral samples
- Weight changes from baseline [ Time Frame: 1 year ]Weight (Kg)
- Blood glucose responses [ Time Frame: 1 year ]Continuous glucose monitoring (CGM),
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
|Contact: Alona Metz, Mscemail@example.com|
|Contact: Aurelie Bukimer, Bscfirstname.lastname@example.org|
|Principal Investigator:||Eran Elinav, Prof||Weizmann Institute of Science|