Omega 7 + 3 Combination and Systemic Inflammation

NCT02155816 | Completed

• 1 other identifier: 14-0160
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation

Keywords

inflammation; lipoproteins; omega 3; omega 7

Outcome Measures

Primary Outcomes (1)

• Change in systemic inflammation as measured with CRP and cytokines

  Effects of 8-weeks supplementation with omegas 7 and 3 fats combination versus omega-3 fats and placebo on systemic inflammation (CRP and cytokine panel).

  8 weeks

Secondary Outcomes (1)

• Change in plasma lipoproteins (cholesterol, triglycerides, LDL-chol, HDL-chol)

  8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

MCT (medium chain triglyceride)

Dietary Supplement: Placebo

Omega 3

EXPERIMENTAL

Omega-3 fatty acid ethyl esters, 2 soft gels of total 1000mg (660mg EPA +340mg DHA)/day.

Dietary Supplement: Omega 3

Omega 7 + 3

EXPERIMENTAL

210mg of Omega-7 fatty acid and 1000mg (660mg EPA +340mg DHA) of Omega-3

Dietary Supplement: Omega 7 + 3

Interventions

Omega 7 + 3 DIETARY_SUPPLEMENT

Ingestion of omega 7 + 3 daily for 8 weeks.

Omega 7 + 3

Omega 3 DIETARY_SUPPLEMENT

Omega 3 daily for 8 weeks.

Omega 3

Placebo DIETARY_SUPPLEMENT

Medium chain triglycerides

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Appalachian State University: lead

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• David Nieman, DrPH

  Appalachian State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 4, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

US (1)