Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs

NCT02855242 | Completed

• 1 other identifier: 16-001912
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in weight loss

  enrolled in exercise program

  baseline to 6 months

Secondary Outcomes (1)

• Changes in gut microbiota

  Baseline to 6 months

Study Arms (2)

Intervention Program Group

OTHER

Lifestyle Counseling

Behavioral: Lifestyle Counseling

Controls Group

ACTIVE COMPARATOR

No lifestyle counseling

Other: Controls Group

Interventions

Lifestyle Counseling BEHAVIORAL

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

Also known as: Obese group participants

Intervention Program Group

Controls Group OTHER

Subjects not participating in any lifestyle counseling

Also known as: No Lifestyle Counseling

Controls Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Purna C Kashyap, M.B.B.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: August 4, 2016
• Study Start: April 1, 2016
• Primary Completion: July 28, 2020
• Study Completion: January 28, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)