Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Lifestyle Counseling; Other: Controls Group

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention Program Group; Lifestyle Counseling	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 Names: Obese group participants
Active Comparator: Controls Group; No lifestyle counseling	Other: Controls Group; Subjects not participating in any lifestyle counseling; Other Names: No Lifestyle Counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight loss	enrolled in exercise program	baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gut microbiota	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	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Purna C Kashyap, M.B.B.S., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): January 28, 2021

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 16-001912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data may be shared with Mayo Clinic research staff involved in this study; outside academic institutions, as specified in the protocol; and the Mayo Clinic Institutional Review Board that oversees the research.