Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs
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|ClinicalTrials.gov Identifier: NCT02855242|
Recruitment Status : Active, not recruiting
First Posted : August 4, 2016
Last Update Posted : April 1, 2021
The human gut microbiota has become the subject of extensive research in recent years, particularly in regards to the role it plays in obesity. Although lifestyle factors, diet, and lack of exercise contribute largely to this obesity epidemic, there is increasing evidence that the human gut microbiota also influences weight gain.
The investigators hope to learn more information about the change in gut microbiota, especially with regards to those who are successful with weight loss, versus those who don't lose weight, after participating in a lifestyle modification program at the Dan Abraham Healthy Living Center (DAHLC).
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Lifestyle Counseling Other: Controls Group||Not Applicable|
The gut microbiome is altered in obesity and is being increasingly studied given its role in energy harvest and fat storage with the hopeful goal of discovering a modifiable intervention to affect obesity and its consequences. Mouse models have already shown that transplantation of an obese microbiota into germ-free mice yields increased adiposity compared to transplantation of a lean microbiota. In humans, initial studies looked at the relative proportion of Bacteroidetes and Firmicutes in obese versus lean individuals and then followed those obese individuals who lost weight on low-calorie diets. The relative proportion of Bacteroidetes was decreased in obese people, and this then increased with weight loss. While certainly provocative, the findings were not consistently reproduced.
Subjects will include members of the Dan Abraham Healthy Living Center (DAHLC) program or the Healthy Living Program (HLP) at Mayo Clinic Rochester, who are seeking advice for weight management concerns.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||March 31, 2022|
Intervention Program Group
Behavioral: Lifestyle Counseling
Participation in weekly group sessions over a period of 10 weeks, with information on healthy nutrition and exercises promoting weight loss
Other Name: Obese group participants
Active Comparator: Controls Group
No lifestyle counseling
Other: Controls Group
Subjects not participating in any lifestyle counseling
Other Name: No Lifestyle Counseling
- Changes in weight loss [ Time Frame: baseline to 6 months ]enrolled in exercise program
- Changes in gut microbiota [ Time Frame: Baseline to 6 months ]Gut microbiota, fecal metabolites will be identified using ultra performance liquid chromatography-mass spectrometry in the CTSA metabolomics core following extraction of fecal water samples
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): NCT02855242
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Purna C Kashyap, M.B.B.S.||Mayo Clinic|