Trial Outcomes & Findings for Improving Metabolic Health in Patients With Diastolic Dysfunction (NCT NCT03448185)

Last Updated: 2023-01-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Baseline, 1 year

Results posted on

2023-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Control Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise. olive oil capsules: Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.	Exercise and Omega-3 Fatty Acids Subjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year. High intensity exercise: 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 oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.	Yoga and Omega-3 Fatty Acids Subjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year. Omega-3 fish oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.	Exercise Control Subjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year. High intensity exercise: 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. olive oil capsules: Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.
Overall Study STARTED	16	24	18	22
Overall Study COMPLETED	13	13	14	16
Overall Study NOT COMPLETED	3	11	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Metabolic Health in Patients With Diastolic Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=16 Participants Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise. olive oil capsules: Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.	Exercise and Omega-3 Fatty Acids n=24 Participants Subjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year. High intensity exercise: 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 oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.	Yoga and Omega-3 Fatty Acids n=18 Participants Subjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year. Omega-3 fish oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.	Exercise Control n=22 Participants Subjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year. High intensity exercise: 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. olive oil capsules: Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.	Total n=80 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 6 • n=5 Participants	50 years STANDARD_DEVIATION 6 • n=7 Participants	47 years STANDARD_DEVIATION 9 • n=5 Participants	50 years STANDARD_DEVIATION 6 • n=4 Participants	49 years STANDARD_DEVIATION 6 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	48 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	32 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	17 Participants n=21 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	18 Participants n=4 Participants	59 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
BMI	36.7 kg/m^2 STANDARD_DEVIATION 5.2 • n=5 Participants	36.7 kg/m^2 STANDARD_DEVIATION 5.3 • n=7 Participants	40.5 kg/m^2 STANDARD_DEVIATION 6.5 • n=5 Participants	36.7 kg/m^2 STANDARD_DEVIATION 5.0 • n=4 Participants	38.9 kg/m^2 STANDARD_DEVIATION 5.7 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline, 1 year

Outcome measures

Outcome measures
Measure	Control n=13 Participants Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise. olive oil capsules: Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.	Exercise and Omega-3 Fatty Acids n=13 Participants Subjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year. High intensity exercise: 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 oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.	Yoga and Omega-3 Fatty Acids n=14 Participants Subjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year. Omega-3 fish oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.	Exercise Control n=16 Participants Subjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year. High intensity exercise: 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. olive oil capsules: 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	-0.16 %fat/water Standard Deviation 1.1	-0.18 %fat/water Standard Deviation 0.59	-0.53 %fat/water Standard Deviation 0.66	-0.19 %fat/water Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline,1 year

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.

Outcome measures

Outcome measures
Measure	Control n=13 Participants Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise. olive oil capsules: Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.	Exercise and Omega-3 Fatty Acids n=13 Participants Subjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year. High intensity exercise: 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 oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.	Yoga and Omega-3 Fatty Acids n=14 Participants Subjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year. Omega-3 fish oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.	Exercise Control n=16 Participants Subjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year. High intensity exercise: 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. olive oil capsules: 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 Peak Volume of Oxygen (VO2)	0.21 ml/kg/min Standard Deviation 1.59	4.39 ml/kg/min Standard Deviation 2.48	-0.03 ml/kg/min Standard Deviation 1.84	4.53 ml/kg/min Standard Deviation 2.65

SECONDARY outcome

Timeframe: Baseline, 1 year

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.

Outcome measures

Outcome measures
Measure	Control n=13 Participants Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise. olive oil capsules: Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.	Exercise and Omega-3 Fatty Acids n=13 Participants Subjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year. High intensity exercise: 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 oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.	Yoga and Omega-3 Fatty Acids n=14 Participants Subjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year. Omega-3 fish oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.	Exercise Control n=16 Participants Subjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year. High intensity exercise: 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. olive oil capsules: 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 Markers of Arterial Stiffness	-15 cm/s Standard Deviation 107	-16 cm/s Standard Deviation 80	32 cm/s Standard Deviation 141	-7 cm/s Standard Deviation 104

SECONDARY outcome

Timeframe: Baseline, 1 year

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.

Outcome measures

Outcome measures
Measure	Control n=13 Participants Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise. olive oil capsules: Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.	Exercise and Omega-3 Fatty Acids n=13 Participants Subjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year. High intensity exercise: 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 oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.	Yoga and Omega-3 Fatty Acids n=14 Participants Subjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year. Omega-3 fish oil: Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year. Yoga: Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.	Exercise Control n=16 Participants Subjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year. High intensity exercise: 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. olive oil capsules: 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 Left Ventricular Mass	0.2 grams Standard Deviation 7.7	7.2 grams Standard Deviation 6.6	-5.8 grams Standard Deviation 10.4	6.0 grams Standard Deviation 10

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise and Omega-3 Fatty Acids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Yoga and Omega-3 Fatty Acids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eriko Iwatate

University of Texas Southwestern Medical Center

Phone: 214-648-3680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place