Fish oil and red wine: a recipe for less inflammation?
NCT ID NCT00682318
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how fish oil and red wine change certain markers in the blood and urine that are linked to inflammation and cell stress. Forty healthy adults will take high doses of fish oil or a placebo, along with red wine or alcohol, to see how these substances affect the body. The goal is to better understand the effects of omega-3 fatty acids and red wine on health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fish oil (omega-3 fatty acids) and red wine
- What this could lead to
- If successful, this could help clarify how omega-3s and red wine affect inflammation and cell stress, potentially guiding future dietary recommendations.
- What could go wrong
- This is a small, early-stage study in healthy volunteers, not designed to prove any health benefit. Results may not apply to people with health conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2008
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
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