Metabolic SyndromeNCT02670382

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

A study testing EPA, DHA and sunflower oil in people with Metabolic Syndrome, run by Tufts University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Metabolic Syndrome
What is being tested?: EPA, DHA and sunflower oil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Jean Mayer Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Metabolic Syndrome
Being tested: EPA, DHA, sunflower oil
Medical subject headings: Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EPADietary supplement
Also called eicosapentaenoic acid
10 week supplementation
DHADietary supplement
10 week supplementation
sunflower oilDietary supplement
4-week lead-in

Study groups in NCT02670382
Study group	Role	What they receive
EPA intervention	Experimental	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. Receives: Dietary Supplement: EPA
DHA intervention	Experimental	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. Receives: Dietary Supplement: DHA
Placebo	Placebo comparator	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. Receives: Dietary Supplement: sunflower oil

What is being measured

The primary outcome is the main question the study is designed to answer.

Interleukin-6 (IL-6)
plasma levels in pg/mL
Measured: 10 weeks
Tumor Necrosis Factor Alpha (TNF-alpha)
plasma levels in pg/mL
Measured: 10 weeks
Low Density Lipoprotein Cholesterol (LDL-C)
plasma levels in mg/dL
Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Oct 2020

First posted1 Feb 2016 (estimated)
Study startMar 2016
Primary completionMay 2020
Study completionOct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02670382
Sponsor's protocol ID: 2845
Status last verified: Apr 2021
First submitted: 23 Dec 2015
Last updated: 14 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of EPA and DHA in Fish Oil on Inflammation and Lipoprotein Metabolism
ClinicalTrials.gov ID: NCT02670382
Acronym / sponsor ID: 2845
Conditions: Metabolic Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Tufts UniversityUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: May 2020 (actual)
Study completion: Oct 2020 (actual)
First posted: 1 Feb 2016 (estimated)
Results: Posted 14 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
EPA intervention	Experimental	Dietary Supplement: EPASubjects 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.
DHA intervention	Experimental	Dietary Supplement: DHASubjects 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.
Placebo	Placebo comparator	Dietary Supplement: sunflower oil3000 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.

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EPAAlso: eicosapentaenoic acid10 week supplementation	Dietary supplement	EPA intervention
DHA10 week supplementation	Dietary supplement	DHA intervention
sunflower oil4-week lead-in	Dietary supplement	Placebo

Primary outcome

Interleukin-6 (IL-6)
Time frame: 10 weeks
plasma levels in pg/mL
Tumor Necrosis Factor Alpha (TNF-alpha)
Time frame: 10 weeks
plasma levels in pg/mL
Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: 10 weeks
plasma levels in mg/dL

Results and safety

Results posted to the registry on 14 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Then EPA, Then DHA	12	10
Placebo, Then DHA, and Then EPA	12	11

Primary outcome: Interleukin-6 (IL-6)

Time frame: 10 weeks. Mean (Standard Deviation). Unit: pg/mL

Measure	Placebo n = 21	EPA Intervention n = 21	DHA Intervention n = 21
Value	0.96 (0.56)	1.01 (0.51)	0.99 (0.77)

Placebo vs EPA Intervention: p = 0.33, Mixed Models Analysis
Placebo vs DHA Intervention: p = 0.92, Mixed Models Analysis
EPA Intervention vs DHA Intervention: p = 0.44, Mixed Models Analysis

Primary outcome: Tumor Necrosis Factor Alpha (TNF-alpha)

Time frame: 10 weeks. Mean (Standard Deviation). Unit: pg/mL

Measure	Placebo n = 21	EPA Intervention n = 21	DHA Intervention n = 21
Value	2.38 (0.54)	2.48 (0.64)	2.47 (0.76)

Placebo vs EPA Intervention: p = 0.34, Mixed Models Analysis
Placebo vs DHA Intervention: p = 0.50, Mixed Models Analysis
EPA Intervention vs DHA Intervention: p = 0.83, Mixed Models Analysis

Primary outcome: Low Density Lipoprotein Cholesterol (LDL-C)

Time frame: 10 weeks. Mean (Standard Deviation). Unit: mg/dL

Measure	Placebo n = 21	EPA Intervention n = 21	DHA Intervention n = 21
Value	130 (26)	136 (26)	140 (32)

Placebo vs EPA Intervention: p = 0.10, Mixed Models Analysis
Placebo vs DHA Intervention: p = 0.005, Mixed Models Analysis
EPA Intervention vs DHA Intervention: p = 0.17, Mixed Models Analysis

Adverse events

Time frame: adeverse events were collected during the participation of study subjects, equivalent to 34 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EPA Intervention	0 of 21 (0%)	0 of 21 (0%)	0 of 21
DHA Intervention	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Placebo	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
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Not yet recruitingPhase 2
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Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
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Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stefania Lamon-Fava, PhD principal investigator

Tufts University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EPA, DHA and sunflower oil in people with Metabolic Syndrome, run by Tufts University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interleukin-6 (IL-6) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02670382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.