Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs



Status:Enrolling by invitation
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:April 2016
End Date:December 2019

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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).

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.

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;
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Purna C Kashyap, M.B.B.S.
Phone: 507-538-0403
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Rochester, MN
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