Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00682318
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT00682318
Study Brief:
Protocol Section:
NCT00682318