Omega 7 + 3 Combination and Systemic Inflammation

Completed · Not applicable · Has a placebo group

Conditions studied: Inflammation

In brief

The purpose of this study is to determine if supplementation with a mixture of omega 7 and 3 fats has a favorable influence on blood inflammation and lipoprotein biomarkers in women with systemic inflammation compared to omega 3 and placebo.

Key facts

Study ID

NCT02155816

Run by

Appalachian State University

People needed

68

Starts

2014-05-01

Expected to finish

2014-08-01

Last updated by the study team

2015-07-16

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 18 to 70 years of age, female
• Body mass index (BMI) 25 kg/m2 and higher
• Generally healthy and without cardiovascular disease
• Ability to understand and the willingness to sign a written informed consent document
• Willingness to maintain current lifestyle
• CRP values greater than or equal to 2 mg/L (established through pre-study screening).

You may not qualify if…

• Subject Exclusion Criteria: Prohibited Medications, Medical Foods or Supplements
• Exclusion criteria include the following prohibited medications, medical foods or nutritional supplements within 14 days prior to and for the duration of the study:
• Regular use of red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, policosanols, or any other supplement for the control blood lipid levels.
• Use of prescription medications to control blood cholesterol and lipids including HMG Coenzyme A reductase inhibitors, bile acid sequestrants, fibrates, cholesterol adsorption blocking agents, or niacin. Common examples include Lipitor, Crestor, Zocor, Pravachol, Mevacor, Vytorin, and Niaspan.
• Regular use of omega 3 fats or fish oil medications and supplements.
• Regular use of antioxidant vitamins or supplements at doses greater than 100% Daily Value levels.
• Regular use of Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). Examples include ibuprofen (Advil, Motrin, Nuprin), naproxen (Aleve, Naprosyn), and COX-2 inhibitors (Celebrex).
• Regular use of medications classified as narcotics (e.g., codeine, Fentora, Lorcet, Vicodin, Demerol, Dolophine, OxyContin, Percocet).
• Regular use of oral or injectable corticosteroids (e.g., cortisone and prednisone).
• Subject Exclusion Criteria: Medical History and Concurrent Diseases
• History of allergy or intolerance to study products including fish oils and omega-7.
• Current diagnosis or personal history of cardiovascular disease including myocardial infarction, angina, cardiovascular surgery, congestive heart failure, cardiac arrhythmias or conduction abnormalities, cerebrovascular accident, transient ischemic attack (TIA), or peripheral vascular disease, deep vein thrombosis or pulmonary embolus.
• Pregnant or planning to be pregnant during the 8-week study, or those breast feeding.
• Subject Exclusion Criteria: Miscellaneous
• Inability to comply with study and/or follow-up visits.
• Any other concurrent condition which, in the opinion of the PI, would preclude participation in this study or interfere with compliance.
• Any other sound medical, psychiatric and/or social reason as determined by the PI.
• Co-enrollment in other trials is restricted other than for observational studies. Study staff should be notified of co-enrollment as it may require the approval of the investigator.

Where it is running

• Appalachian State University Human Performance Lab, North Carolina Research Campus — Kannapolis, North Carolina, United States

Full record on ClinicalTrials.gov

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