Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Lifestyle Counseling; Other: Controls Group

• Registration Number: NCT02855242
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Primary Completion: 2020-07-28
• Study Completion: 2021-01-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Adults aged 18 and above;
• Subjects who are overweight or obese (BMI of 25 or greater);
• DAHLC/HLP eligible members who are able to access DAHLC support services;

Exclusion Criteria

• Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions;
• Antibiotic use within the past 4 weeks (they can be enrolled after a four week washout period and subsequent use during the 6 month study duration does not exclude them);
• Bowel preparation for colonoscopy within the past week;
• Pregnancy or plans to become pregnant within the study time frame;
• Vulnerable Adults;
• Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Program Group	Lifestyle Counseling	Lifestyle Counseling
Controls Group	Controls Group	No lifestyle counseling

Primary Outcome Measures

Name	Time	Method
Changes in weight loss	baseline to 6 months	enrolled in exercise program

Secondary Outcome Measures

Name	Time	Method
Changes in gut microbiota	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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States