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Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs

Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02855242
Enrollment
32
Registered
2016-08-04
Start date
2016-04-30
Completion date
2021-01-28
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALLifestyle Counseling

Participation in weekly group sessions over a period of 10 weeks, with information on healthy nutrition and exercises promoting weight loss

OTHERControls Group

Subjects not participating in any lifestyle counseling

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Changes in weight lossbaseline to 6 monthsenrolled in exercise program

Secondary

MeasureTime frameDescription
Changes in gut microbiotaBaseline to 6 monthsGut microbiota, fecal metabolites will be identified using ultra performance liquid chromatography-mass spectrometry in the CTSA metabolomics core following extraction of fecal water samples

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026