An interventional study of High intensity exercise and Omega-3 fish oil in Obesity, Heart Failure, Diastolic and Metabolic Syndrome, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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Among 16 studies testing Fish Oils in Obesity — 1 open to participants now, 1 under way, none of them phase 3. Fish Oils · Obesity.
Among the 16 studies testing Fish Oils in Obesity, this one is the 6th largest by enrollment, is one of 2 that started in 2015, is one of 11 with no phase, and was the 12th registered.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
Browse Obesity studies →1 of the 16 studies testing Fish Oils in Obesity is open now, in 1 country. Recruiting first, the newest first:
May Faraj, PDt, PhD · Sites in Canada
Ages 40–70 · Healthy volunteers
By country, each count listing its studies:
Fish Oils: first FDA approval 2016 (SMOFLIPID 20%). What it is approved for, and how studies give it, is on its page →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.
This study: 40 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 1989; this study’s year is marked. 2 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is above the median of 67 across 9,010 interventional studies indexed under Obesity.
Median enrollment 66 across the 16 interventional studies. Of the 13 that completed or were terminated, 1 (8%) have results posted.
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1 of 16 have an industry lead sponsor. The 10 most frequent:
University of Texas Southwestern Medical Center is the lead sponsor of 1,012 studies on the registry; 201 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
31 studies in Obesity by University of Texas Southwestern Medical Center: 7 open now, 8 under way, none of them phase 3. Of 23 finished, 13 (57%) have results posted.
Among the 31 studies in Obesity by University of Texas Southwestern Medical Center, this one is the 8th largest by enrollment of the 24 interventional ones that give a count, is the only one that started in 2015, is one of 16 with no phase, and was the 17th registered.
University of Texas Southwestern Medical Center’s Obesity studies by the year they started, since 2007.
None of the studies under way reaches primary completion within a year.
Among the 16 studies testing Fish Oils in Obesity, from their registry updates:
Among University of Texas Southwestern Medical Center’s 31 in Obesity:
This tab as a report to print or save as PDF → With an account.
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.
The global objective of this project is to test novel strategies to prevent obesity related abnormalities in diastolic function that may progress to heart failure with preserved ejection fraction (HFpEF). These include: a) identifying high risk individuals by using population derived imaging and blood biomarkers; and b) implementing novel exercise training and "nutri-ceutical" strategies in obese middle aged individuals with high amounts of visceral fat, an important risk factor in the development of heart failure and adverse cardiac remodeling.
Prior work has demonstrated that: a) high levels of myocardial triglyceride content are associated with a smaller and less distensible left ventricle with reduced tissue relaxation rates compared to those with low levels and b) low fitness and high body mass index were the strongest predictors of elevated myocardial content. The consequences of excess visceral adiposity (intra- and retro-peritoneal adipose tissue) on cardiac remodeling suggest individuals with high visceral fat content and low fitness are at particularly high risk for heart failure.
The primary objective of this project is therefore to identify high risk, sedentary, middle aged obese individuals with high visceral fat levels, and initiate an exercise program in conjunction with omega-3 fatty acid supplementation designed to reduce visceral adiposity and regress myocardial triglyceride accumulation. Findings from this aim would have enormous public health significance and establish a novel, practical exercise training program and "nutria-ceutical" strategy to reverse obesity related cardiovascular remodeling.
Hypothesis:
High aerobic exercise training in conjunction with daily omega-3 supplementation will reduce visceral myocardial triglyceride accumulation by reducing visceral adiposity. A reduction of myocardial fat will lead to improved LV structure and diastolic function by an approach that is not necessarily predicated on weight loss.
Specific Aim:
To test our hypothesis that reduction in myocardial triglyceride content will improve markers of diastolic function, we have designed a randomized, double blind, placebo controlled trial. We will study four groups of previously sedentary obese middle aged subjects at high risk for development of HF for one year with the following interventions: A) sedentary controls taking placebo; B) sedentary subjects taking omega-3 fatty acids; C) subjects undergoing high intensity aerobic exercise training while on placebo and D) subjects undergoing high intensity aerobic exercise training while taking omega-3 fatty acids. Subjects will be categorized as high risk and enrolled on the basis of elevated serum biomarkers (cTnT) and high visceral fat content (>2.5 kg). We will perform comprehensive non-invasive assessments of cardiovascular structure and systolic/diastolic function before and after 1 year of an exercise intervention involving high intensity intervals and omega-3 administration. We anticipate the combination of high intensity aerobic exercise in conjunction with high dose omega-3 supplementation will reduce visceral adiposity, decrease myocardial triglyceride content and improve markers of diastolic and vascular function.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year.
Behavioral: Yoga · Dietary Supplement: olive oil capsules
Subjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year.
Behavioral: High intensity exercise · Dietary Supplement: Omega-3 fish oil
Subjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year.
Dietary Supplement: Omega-3 fish oil · Behavioral: Yoga
Subjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year.
Behavioral: High intensity exercise · Dietary Supplement: olive oil capsules
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.
Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.
Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.
Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.
Change From Baseline at 1 Year in Myocardial Lipid Content
Myocardial triglyceride (lipid) content will be measured using cardiac nuclear magnetic resonance spectroscopy. We quantified the total myocardial triglyceride (TG) resonance from water-suppressed spectra. Myocardial TG content relative to water (%) as well as relative amounts of myocardial TG was calculated from the available data.
Time frame: Baseline, 1 year
Change From Baseline at 1 Year in Peak Volume of Oxygen (VO2)
Change in peak VO2 (normalized for body weight those who completed the study). Peak VO2 is a measure how well the heart and lungs are working during exercise.
Time frame: Baseline,1 year
Change From Baseline at 1 Year in Markers of Arterial Stiffness
Changes in arterial stiffness is measured using pulse-wave velocity (PWV) to look at intervention effects from baseline to 1 year in the control and treatment groups.
Time frame: Baseline, 1 year
Change From Baseline at 1 Year in Left Ventricular Mass
Change in left ventricular mass is measured by cardiac MRI to look at intervention effects from baseline to 1 year in the control and treatment groups.
Time frame: Baseline, 1 year
| Milestone | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control |
|---|---|---|---|---|
| Started | 16 | 24 | 18 | 22 |
| Completed | 13 | 13 | 14 | 16 |
| Not completed | 3 | 11 | 4 | 6 |
Myocardial triglyceride (lipid) content will be measured using cardiac nuclear magnetic resonance spectroscopy. We quantified the total myocardial triglyceride (TG) resonance from water-suppressed spectra. Myocardial TG content relative to water (%) as well as relative amounts of myocardial TG was calculated from the available data.
| %fat/water | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control |
|---|---|---|---|---|
| Change From Baseline at 1 Year in Myocardial Lipid Content | -0.16 ± 1.1 | -0.18 ± 0.59 | -0.53 ± 0.66 | -0.19 ± 0.42 |
Change in peak VO2 (normalized for body weight those who completed the study). Peak VO2 is a measure how well the heart and lungs are working during exercise.
| ml/kg/min | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control |
|---|---|---|---|---|
| Change From Baseline at 1 Year in Peak Volume of Oxygen (VO2) | 0.21 ± 1.59 | 4.39 ± 2.48 | -0.03 ± 1.84 | 4.53 ± 2.65 |
Changes in arterial stiffness is measured using pulse-wave velocity (PWV) to look at intervention effects from baseline to 1 year in the control and treatment groups.
| cm/s | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control |
|---|---|---|---|---|
| Change From Baseline at 1 Year in Markers of Arterial Stiffness | -15 ± 107 | -16 ± 80 | 32 ± 141 | -7 ± 104 |
Change in left ventricular mass is measured by cardiac MRI to look at intervention effects from baseline to 1 year in the control and treatment groups.
| grams | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control |
|---|---|---|---|---|
| Change From Baseline at 1 Year in Left Ventricular Mass | 0.2 ± 7.7 | 7.2 ± 6.6 | -5.8 ± 10.4 | 6.0 ± 10 |
Collected over 1 year, during study period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Exercise and Omega-3 Fatty Acids | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Yoga and Omega-3 Fatty Acids | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Exercise Control | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(years) | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control | Total |
|---|---|---|---|---|---|
| Mean | 49 ± 6 | 50 ± 6 | 47 ± 9 | 50 ± 6 | 49 ± 6 |
| Sex: Female, Male(Participants) | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control | Total |
|---|---|---|---|---|---|
| Female | 11 | 15 | 10 | 12 | 48 |
| Male | 5 | 9 | 8 | 10 | 32 |
| Race (NIH/OMB)(Participants) | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 0 | 2 |
| Asian | 0 | 0 | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 6 | 3 | 17 |
| White | 12 | 18 | 11 | 18 | 59 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| BMI(kg/m^2) | Control | Exercise and Omega-3 Fatty Acids | Yoga and Omega-3 Fatty Acids | Exercise Control | Total |
|---|---|---|---|---|---|
| Mean | 36.7 ± 5.2 | 36.7 ± 5.3 | 40.5 ± 6.5 | 36.7 ± 5.0 | 38.9 ± 5.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2015 to primary completion in Jul 2019, 49 months.
Results were first posted in Jan 2023, 3 years 6 months after primary completion.
Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 49 months is above that.
Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fish Oils
University of Texas Southwestern Medical Center →