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HealthyNCT00682318

Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers

A study testing Fish Oil, Safflower Oil and Ethanol in people with Healthy, run by Carsten Skarke, MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk… Read more about this study

Who is it for?
Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Fish Oil, Safflower Oil and Ethanol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
May 2008to Nov 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 21 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age between 21 - 60,
  • Subjects must be in good health as based on medical history, physical examination, vital signs, and laboratory tests.
  • All Subjects have to adhere to the following criteria:
  • Must be non-smoking volunteers (both male and non-pregnant females) due to a significant influence of smoking and overweight on the outcome measures of lipid peroxidation,
  • Must be of normal weight with a body mass index (BMI) ≤ 25. The correlation between the BMI number and body fatness is fairly strong; however it varies by sex, race, and age. These variations include the following examples: At the same BMI, women tend to have more body fat than men; at the same BMI, older people, on average, tend to have more body fat than younger adults; highly trained athletes may have a high BMI because of increased muscularity rather than increased body fatness; source at http://www.cdc.gov/healthyweight/assessing/bmi/adult_BMI/index.html. Therefore, subjects with a BMI > 25 can be enrolled at the discretion of the PI in writing.
  • Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, depo-provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and just prior to the start of each treatment phase of the study (first study visit, every ethanol administration visit, at first visit of fish oil administration), and during the third week of fish oil administration. All pregnancy tests must be negative at all time points.
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  • Male subjects must be surgically sterile and/or agree to use condoms throughout the duration of the study.
  • Persons who consume vitamin supplements are required to undergo a "washout period" of ≥ five weeks without supplement prior to study enrollment (in analogy to Block G, et al. Am J Epidemiol 2002; 156: 274)
  • Urine ethanol assessment indicating abstinence.

Who cannot join

  • Female subjects who are pregnant or nursing a child.
  • Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
  • Subjects with any coagulation, bleeding or blood disorders.
  • Subjects with nutritional inefficiencies in Fe, Zn, Cu, Mg (according to 61)
  • Subjects who are sensitive or allergic to fish, fish oil or fish-containing products.
  • Subjects with any evidence of cancer or history of significant cardiovascular disease (including stroke or TIA), renal, hepatic, respiratory, endocrine, metabolic, hematopoietic or neurological disorder.
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  • Subjects with a systolic blood pressure above 160 or a diastolic blood pressure above 95,
  • Subjects with any evidence of GI disorders that could interfere with fat absorption
  • Subjects with an intention to lose weight during their participation in the trial
  • Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject. Subjects who have had a history of drug or alcohol abuse within the last 6 months.
  • Carbohydrate-deficient transferrin > 6% indicating chronic alcohol abuse
  • Complete abstinence from alcohol
  • Intake of more than three alcoholic drinks per day
  • Subjects with a history of cancer, including skin cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers: a Randomized Double-blinded Trial on the Modulation of the Eicosanoid and Isoprostane Pathways in Healthy Subjects by Omega-3 Polyunsaturated Fatty Acids and Red Wine.

The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs.

The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.

Read the detailed description

This clinical study comprises several parts:

Part 1: Single-arm open oral administration of ethanol in n=40 healthy participants.

Part 1.1: Single-arm open oral administration of fish oil capsules and ethanol in n=12 healthy participants.

Part 2a: Randomized double-blind oral administration of fish oil or safflower oil capsules and ethanol in n=44 healthy participants.

Part 2b: Randomized double-blind oral administration of fish foods or control diet and open oral administration of ethanol in n=40 healthy participants.

Part 3: Randomized double-blind oral administration of fish foods or control diet and red wine beverages in n=40 healthy participants.

Conditions
Healthy
Being tested
Fish Oil, Safflower Oil, Ethanol, Omega-3 polyunsaturated fatty acids, Omega-6 polyunsaturated fatty acid
Keywords
Fish oil, red wine, alcohol, oxidative stress, Healthy volunteers

What participants receive

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

  • Fish OilDrug

    Also called LovazaTM (former name: Omacor®)

    Part 1.1: Dose of 9.3 g/day EPA plus 7.5 g/day DHA;

    Part 2a (run-in phase): Dose of 1 time 2 capsules per day of Lovaza (total of 1.7 g/d ω-3 PUFA consisting of 930 mg/day EPA and 750 mg/day DHA) for 29±1 days;

    Part 2a (study arm): Dose of 3 times 4 capsules per day of Lovaza (total of 10.1 g/d ω-3 PUFA consisting of 5580 mg/day EPA and 4500 mg/day DHA) for 29±1 days

  • Safflower OilDietary supplement

    Also called Omega-6 polyunsaturated fatty acids

    Part 2a: (Study Arm): Omega-6 polyunsaturated fatty acids 3 times 4 capsules per day (total of 10.2 g/d ω-6 PUFA) for 29±1 days

  • EthanolDietary supplement

    Part 1 \& Part 1.1:

    Dose of 0.9 g/kg body weight 98% alcohol solution

    Part 2a:

    Doses of 0.4 and 0.9 g/kg body weight 98% alcohol solution and a control placebo drinking solution

    Part 2b, Part 3:

    Doses of 0.4, 0.6 and 0.9 g/kg body weight 98% alcohol solution

  • Omega-3 polyunsaturated fatty acidsDietary supplement

    Also called n-3 PUFA alimentary supplementation

    Part 2b:

    Alimentary diet delivering ≈ 500 mg/day EPA/DHA,or Alimentary diet delivering ≈ 900-1000 mg/day EPA/DHA, or Alimentary diet delivering ≈ 1500-1800 mg/day EPA/DHA;

    Part 3:

    Alimentary diet delivering EPA/DHA in a quantity to be determined by Part 2b.

  • Omega-6 polyunsaturated fatty acidDietary supplement

    Also called n-6 PUFA alimentary supplementation

    Part 2b:

    Control omega-6 fatty acid alimentary diet (<130 mg/day EPA/DHA)

Study groups in NCT00682318
Study groupRoleWhat they receive
Fish oilExperimentalOmega-3 polyunsaturated fatty acids (n-3 PUFA)
Receives: Drug: Fish Oil; Dietary Supplement: Ethanol; Dietary Supplement: Omega-3 polyunsaturated fatty acids
Safflower OilActive comparatorOmega-6 polyunsaturated fatty acids (n-6 PUFA)
Receives: Dietary Supplement: Safflower Oil; Dietary Supplement: Ethanol; Dietary Supplement: Omega-6 polyunsaturated fatty acid

What is being measured

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

  1. Urinary isoprostane concentrations

    urinary isoprostanes will be analyzed raw (i.e. untransformed, including the Time factor: Baseline vs Peak)

    Measured: Hours and days

Secondary outcomes (5)

  1. Urinary eicosanoid concentrations

    Time-dependency of urine eicosanoid and isoprostane formation after acute oral ethanol

    Measured: Hours and days

  2. Plasma eicosanoid concentrations

    plasma eicosanoid response after a single oral dose of 0.9 g/kg body weight 98% ethanol.

    Measured: Hours and days

  3. Blood alcohol concentrations

    Evaluation of acute toxic alcohol effects

    Measured: Hours and days

  4. Blood fatty acid composition

    Oral administration of omega-3 and omega-6 fatty acids

    Measured: Hours to months

  5. Compositional Changes in the Intestinal Microbiome

    Collection of stool samples

    Measured: Hours and days

Timeline

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

  1. First posted22 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00682318
Sponsor's protocol ID
807069
Status last verified
Feb 2026
First submitted
16 May 2008
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Fish Oil, Safflower Oil and Ethanol in people with Healthy, run by Carsten Skarke, MD 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 9 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Urinary isoprostane concentrations (time frame: Hours and days). 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 NCT00682318.

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 24 Feb 2026.

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