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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
Sponsor:
Information provided by (Responsible Party):
Purna C. Kashyap, MBBS, 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).


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Lifestyle Counseling Other: Controls Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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 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




Primary Outcome Measures :
  1. Changes in weight loss [ Time Frame: baseline to 6 months ]
    enrolled in exercise program


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Purna C Kashyap, M.B.B.S. Mayo Clinic
Additional Information:
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Responsible Party: Purna C. Kashyap, MBBS, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02855242    
Other Study ID Numbers: 16-001912
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.