"Mayo Clinic Diet" Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes (PHENO-Diet Trial)

Mayo Clinic1 site in 1 country215 target enrollmentJuly 6, 2020

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Mayo Clinic
Enrollment: 215
Locations: 1
Primary Endpoint: 12-week total body weight loss
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.

Registry

clinicaltrials.gov

Start Date

July 6, 2020

End Date

January 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Andres J. Acosta, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Adults with obesity (BMI \>30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina).
•Age: 18-65 years.
•Gender: Men or women.

Exclusion Criteria

•Weight change greater than 3% in the previous 3 months (weight stable).
•History of bariatric surgery including lap band and bariatric endoscopy.
•Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
•Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM
•A positive score on the AUDIT-C questionnaire as judged by an investigator.
•Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence