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:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT02333461
Eligibility Criteria:
Inclusion Criteria:
* Overweight/obese (BMI of 25-35 kg/m2) men and women.
* Participant must be 18-70 years of age.
* Considered healthy with no evidence of chronic diseases.
* Willing to maintain a consistent diet and exercise pattern throughout the duration of the study.
* Willing to consume a dairy and egg-based fat challenge meal twice, at start and end of study (V2 \& V3).
Exclusion Criteria:
* History of allergic reaction to fruit, dairy or egg products.
* Current smoker or history of tobacco use within the past year.
* Use of dietary supplements within 1 week prior to Visit 2 and unwilling to refrain from use through the duration of the trial. Supplements include any vitamins, minerals, and herbal products, including herbal drinks.
* Use of fish oil supplements within the past 8 weeks.
* Consumption of fatty fish one or more times per week within the past 8 weeks (e.g., mackerel, salmon, trout, canned albacore tuna, sardines, haddock, cod, hake, halibut, shrimp, sole, flounder, perch, black bass, swordfish, oysters, Alaskan king crab).
* Presence of cardiovascular disease, cancer, diabetes mellitus, inflammatory bowel disease, lactose intolerance, or any other chronic health condition identified from the findings of the interview.
* History of gastric bypass or other surgery that physically alters the gastrointestinal tract.
* Blood pressure greater \> 140 mm Hg systolic or \> 90 mm Hg diastolic during seated, resting measurement on two consecutive occasions during visit 1.
* Fasting serum triglycerides \> 200 mg/dl.
* Use of lipid lowering medications or dietary supplements.
* Use of blood pressure lowering medications or dietary supplements.
* Use of Coumadin, aspirin, or other medications that influence hemostasis.
* Daily use of low dose (\< 81 mg) aspirin is allowed.
* Use of antibiotics within the past week.
* Chronic or therapeutic use of antacids, H2 agonists, and proton pump inhibitors.
* Use of selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, and/or any other drug with vasoconstricting properties.
* Pregnant or lactating women, or women of child-bearing potential unwilling to use a medically approved form of birth control.
* History, in the past year, of current abuse of drugs or alcohol, or intake \> 14 alcoholic beverages per week.
* Participation in another clinical trial within 28 days of enrollment into the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02333461
Study Brief:
Protocol Section:
NCT02333461