MedDataX Logo

Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs

NCT ID: NCT02855242

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-01-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Program Group

Lifestyle Counseling

Group Type OTHER

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

Controls Group

No lifestyle counseling

Group Type ACTIVE_COMPARATOR

Controls Group

Intervention Type OTHER

Subjects not participating in any lifestyle counseling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lifestyle Counseling

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

Intervention Type BEHAVIORAL

Controls Group

Subjects not participating in any lifestyle counseling

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Obese group participants No Lifestyle Counseling

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Purna C. Kashyap, MBBS

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Purna C Kashyap, M.B.B.S.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16-001912

Identifier Type: -

Identifier Source: org_study_id