Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers

NCT00682318 | Active Not Recruiting

• 1 other identifier: 807069
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy

Keywords

Fish oil; red wine; alcohol; oxidative stress; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Urinary isoprostane concentrations

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

  Hours and days

Secondary Outcomes (5)

• Urinary eicosanoid concentrations

  Hours and days

• Plasma eicosanoid concentrations

  Hours and days

• Blood alcohol concentrations

  Hours and days

• Blood fatty acid composition

  Hours to months

• Compositional Changes in the Intestinal Microbiome

  Hours and days

Other Outcomes (1)

• Metabolomics, Lipidomics, Transcriptomics

  Baseline, after low and high doses of fish oil supplementation, after high doses of safflower oil supplementation, after ethanol ingestion

Study Arms (2)

Fish oil

EXPERIMENTAL

Omega-3 polyunsaturated fatty acids (n-3 PUFA)

Drug: Fish Oil; Dietary Supplement: Ethanol; Dietary Supplement: Omega-3 polyunsaturated fatty acids

Safflower Oil

ACTIVE COMPARATOR

Omega-6 polyunsaturated fatty acids (n-6 PUFA)

Dietary Supplement: Safflower Oil; Dietary Supplement: Ethanol; Dietary Supplement: Omega-6 polyunsaturated fatty acid

Interventions

Fish Oil DRUG

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

Also known as: LovazaTM (former name: Omacor®)

Fish oil

Safflower Oil DIETARY_SUPPLEMENT

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

Also known as: Omega-6 polyunsaturated fatty acids

Safflower Oil

Ethanol DIETARY_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

Fish oil; Safflower Oil

Omega-3 polyunsaturated fatty acids DIETARY_SUPPLEMENT

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.

Also known as: n-3 PUFA alimentary supplementation

Fish oil

Omega-6 polyunsaturated fatty acid DIETARY_SUPPLEMENT

Part 2b: Control omega-6 fatty acid alimentary diet (\<130 mg/day EPA/DHA)

Also known as: n-6 PUFA alimentary supplementation

Safflower Oil

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• American Heart Association: collaborator
• Carsten Skarke, MD: lead

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Fish Oils; Safflower Oil; Ethanol; Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alcohols; Organic Chemicals; Fatty Acids, Omega-3; Fatty Acids, Unsaturated; Fatty Acids

Study Officials

• Garret A FitzGerald, M.D.

  Institute for Translational Medicine & Therapeutics, School of Medicine

  PRINCIPAL INVESTIGATOR

• Carsten Skarke, M.D.

  Institute for Translational Medicine & Therapeutics, SOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor of Medicine, Institute for Translational Medicine and Therapeutics, ITMAT

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 22, 2008
• Study Start: May 1, 2008
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)