An interventional study of EPA and DHA in Metabolic Syndrome, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-14.
Sponsored by Tufts University · Not applicable, Interventional, and Treatment
The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.
This is a randomized, placebo-controlled, double-blind, crossover study of the effects of EPA and DHA on inflammation and lipid metabolism in 24 men and women with metabolic syndrome. The study will characterize the effects of EPA alone and DHA alone, relative to each other and to placebo, on plasma biomarkers of inflammation, inflammatory cell activation and gene expression, and plasma lipid and lipoprotein levels.
1,963 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 1,459 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
at least one of the following criteria for the definition of metabolic syndrome:
Exclusion criteria:
Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
Dietary Supplement: EPA
Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
Dietary Supplement: DHA
3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.
Dietary Supplement: sunflower oil
10 week supplementation
Also known as: eicosapentaenoic acid
10 week supplementation
4-week lead-in
Interleukin-6 (IL-6)
plasma levels in pg/mL
Time frame: 10 weeks
Tumor Necrosis Factor Alpha (TNF-alpha)
plasma levels in pg/mL
Time frame: 10 weeks
Low Density Lipoprotein Cholesterol (LDL-C)
plasma levels in mg/dL
Time frame: 10 weeks
405 subjects were screened for eligibility at the Metabolic Research Unit of the Human Nutrition Research Center on Aging at Tufts Unoversity
| Milestone | Placebo, Then EPA, Then DHA | Placebo, Then DHA, and Then EPA |
|---|---|---|
| Started | 12 | 12 |
| Completed | 10 | 11 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Milestone | Placebo, Then EPA, Then DHA | Placebo, Then DHA, and Then EPA |
|---|---|---|
| Started | 10 | 11 |
| Completed | 10 | 11 |
| Not completed | 0 | 0 |
| Milestone | Placebo, Then EPA, Then DHA | Placebo, Then DHA, and Then EPA |
|---|---|---|
| Started | 10 | 11 |
| Completed | 10 | 11 |
| Not completed | 0 | 0 |
plasma levels in pg/mL
| pg/mL | Placebo | EPA Intervention | DHA Intervention |
|---|---|---|---|
| Interleukin-6 (IL-6) | 0.96 ± 0.56 | 1.01 ± 0.51 | 0.99 ± 0.77 |
plasma levels in pg/mL
| pg/mL | Placebo | EPA Intervention | DHA Intervention |
|---|---|---|---|
| Tumor Necrosis Factor Alpha (TNF-alpha) | 2.38 ± 0.54 | 2.48 ± 0.64 | 2.47 ± 0.76 |
plasma levels in mg/dL
| mg/dL | Placebo | EPA Intervention | DHA Intervention |
|---|---|---|---|
| Low Density Lipoprotein Cholesterol (LDL-C) | 130 ± 26 | 136 ± 26 | 140 ± 32 |
Collected over adeverse events were collected during the participation of study subjects, equivalent to 34 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EPA Intervention | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| DHA Intervention | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Placebo | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Event | EPA Intervention | DHA Intervention | Placebo |
|---|---|---|---|
| goutMetabolism and nutrition disorders | 0/21 | 0/21 | 1/21 |
| hypertensionCardiac disorders | 0/21 | 0/21 | 1/21 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 62 ± 6 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 12 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 18 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 21 |
| Body mass index(kg/m^2) | All Participants |
|---|---|
| Mean | 32.20 ± 6.61 |
| C reactive protein(microg/mL) | All Participants |
|---|---|
| Mean | 6.0 ± 3.4 |
| Glucose(mg/dL) | All Participants |
|---|---|
| Mean | 99 ± 11 |
| triglycerides(mg/dL) | All Participants |
|---|---|
| Mean | 145 ± 51 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The objective of this study is to provide critical information regarding both common and distinctive roles of the omega-3 fatty acids EPA and DHA in systemic inflammation and lipid metabolism.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Tufts University