A Study of Changes to the Microbe Environment in the Intestines of Obese People who Modify Their Diet and Lifestyle
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-001912
NCT ID: NCT02855242
Sponsor Protocol Number: 16-001912
About this study
The purpose of this study is to assess changes that occur in the intestine microbe environment of obese people as they perticipate in a structured diet and lifestyle modification.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Obese subjects
- Adults aged 18 and above
- Overweight or obese (BMI of 25 or greater)
- DAHLC/HLP eligible members who are able to access DAHLC support services
- Control subjects
- Adults aged 18 and above
- Overweight or obese (BMI of 25 or greater)
- Preferably lives in the same household, such as a spouse, relative, or contact of the subject, with a similar weight, and not exercising on a regular basis
Exclusion Criteria
- Obese subjects
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions
- Antibiotic use within the past 4 weeks
- 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 adversely affect study outcomes
- Control subjects
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions
- Antibiotic use within the past 4 weeks
- 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 adversely affect study outcomes
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Purna Kashyap, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available