CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
High intensity exercise +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03448185
NCT03448185N/ACompleted

Reduction of Cardiac Steatosis and Improvement of Diastolic Function by Modulating Metabolic Health in Obese Individuals

University of Texas Southwestern Medical Center·interventional·Posted Feb 27, 2018·Updated Jan 5, 2023

In Brief

A clinical study evaluating High intensity exercise, Omega-3 fish oil, and 2 other interventions for Obesity and 2 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether 1 year of supervised exercise training in obese individuals at high risk for developing HF, incorporating high intensity interval training (HIIT) two to three times per week in conjunction with daily oral administration of omega-3 poly-unsaturated fatty acids will lead to reduction in visceral adiposity, regression of myocardial triglyceride levels and improvements in cardiac diastolic and vascular function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 27, 2018
Enrollment StartJun 1, 2015
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.3 years ago

Interventions

High intensity exercisebehavioral

Subjects will be randomized to the exercise groups will undergo 1 year aerobic exercise training comprised of high intensity exercise sessions 2-3 days per week. Sessions will be supervised remotely via heart rate monitors.

Omega-3 fish oildietary

Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.

Yogabehavioral

Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.

olive oil capsulesdietary

Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.