Skip to main content
OpenTrials
Completed

NCT Number: NCT02855242

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Lifestyle Counseling

Behavioral

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

Controls Group

Other

Subjects not participating in any lifestyle counseling

Other names: No Lifestyle Counseling

Primary outcomes

  1. Changes in weight loss

    Time frame: baseline to 6 months

    enrolled in exercise program

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Aug 4, 2016
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.