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Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids

Role of EPA and DHA in Fish Oil on Inflammation and Lipoprotein Metabolism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670382
Enrollment
24
Registered
2016-02-01
Start date
2016-03-31
Completion date
2020-10-31
Last updated
2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTEPA

10 week supplementation

DIETARY_SUPPLEMENTDHA

10 week supplementation

DIETARY_SUPPLEMENTsunflower oil

4-week lead-in

Sponsors

Tufts University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* fasting plasma TG levels between 150 and 500 mg/dL * C-reactive protein (CRP) levels ≥2 µg/mL * at least one of the following criteria for the definition of metabolic syndrome: * abdominal obesity (waist circumference \>40 inches in men and \>35 inches in women), * hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and * fasting glucose ≥110 mg/dL.

Exclusion criteria

* high-fish diets (\>2 fish meals/week) * taking fish oil supplements or supplements containing EPA or DHA * allergy to sardines * allergy to sunflower oil * regular use of anti-inflammatory medications (NSAID, COX inhibitors, corticosteroids) * anticoagulant therapy * alcohol consumption \>7 drinks/week * uncontrolled thyroid dysfunction * insulin-dependent type 2 diabetes mellitus * kidney or liver disease * smoking * alterations in coagulation * use of lipid altering medications

Design outcomes

Primary

MeasureTime frameDescription
Interleukin-6 (IL-6)10 weeksplasma levels in pg/mL
Tumor Necrosis Factor Alpha (TNF-alpha)10 weeksplasma levels in pg/mL
Low Density Lipoprotein Cholesterol (LDL-C)10 weeksplasma levels in mg/dL

Countries

United States

Participant flow

Recruitment details

405 subjects were screened for eligibility at the Metabolic Research Unit of the Human Nutrition Research Center on Aging at Tufts Unoversity

Pre-assignment details

24 subjects met the inclusion criteria and were enrolled into the study. 3 subjects dropped off during the placebo lead-in phase of the study

Participants by arm

ArmCount
All Participants
Baseline characteristic, defined as end of lead-in phase
21
Total21

Withdrawals & dropouts

PeriodReasonFG000FG001
Placebo lead-in PhaseWithdrawal by Subject21

Baseline characteristics

CharacteristicAll Participants
Age, Continuous62 years
STANDARD_DEVIATION 6
Body mass index32.20 kg/m^2
STANDARD_DEVIATION 6.61
C reactive protein6.0 microg/mL
STANDARD_DEVIATION 3.4
Glucose99 mg/dL
STANDARD_DEVIATION 11
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
18 Participants
Region of Enrollment
United States
21 participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
9 Participants
triglycerides145 mg/dL
STANDARD_DEVIATION 51

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 210 / 21
other
Total, other adverse events
0 / 210 / 211 / 21
serious
Total, serious adverse events
0 / 210 / 210 / 21

Outcome results

Primary

Interleukin-6 (IL-6)

plasma levels in pg/mL

Time frame: 10 weeks

ArmMeasureValue (MEAN)Dispersion
PlaceboInterleukin-6 (IL-6)0.96 pg/mLStandard Deviation 0.56
EPA InterventionInterleukin-6 (IL-6)1.01 pg/mLStandard Deviation 0.51
DHA InterventionInterleukin-6 (IL-6)0.99 pg/mLStandard Deviation 0.77
p-value: 0.33Mixed Models Analysis
p-value: 0.92Mixed Models Analysis
p-value: 0.44Mixed Models Analysis
Primary

Low Density Lipoprotein Cholesterol (LDL-C)

plasma levels in mg/dL

Time frame: 10 weeks

ArmMeasureValue (MEAN)Dispersion
PlaceboLow Density Lipoprotein Cholesterol (LDL-C)130 mg/dLStandard Deviation 26
EPA InterventionLow Density Lipoprotein Cholesterol (LDL-C)136 mg/dLStandard Deviation 26
DHA InterventionLow Density Lipoprotein Cholesterol (LDL-C)140 mg/dLStandard Deviation 32
p-value: 0.1Mixed Models Analysis
p-value: 0.005Mixed Models Analysis
p-value: 0.17Mixed Models Analysis
Primary

Tumor Necrosis Factor Alpha (TNF-alpha)

plasma levels in pg/mL

Time frame: 10 weeks

ArmMeasureValue (MEAN)Dispersion
PlaceboTumor Necrosis Factor Alpha (TNF-alpha)2.38 pg/mLStandard Deviation 0.54
EPA InterventionTumor Necrosis Factor Alpha (TNF-alpha)2.48 pg/mLStandard Deviation 0.64
DHA InterventionTumor Necrosis Factor Alpha (TNF-alpha)2.47 pg/mLStandard Deviation 0.76
p-value: 0.34Mixed Models Analysis
p-value: 0.5Mixed Models Analysis
p-value: 0.83Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026