Influence of Omega 7 + 3 Combination on Systemic Inflammation and Plasma Lipoproteins in Women: a 2-month, Double Blind, Placebo-Controlled, Randomized Community Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in systemic inflammation as measured with CRP and cytokines
研究概览
简要总结
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.
详细描述
Background Information and Scientific Rationale
Consumption of long-chain n-3 polyunsaturated fatty acids (n-3 PUFAs), including eicosapentaenoic acid (EPA; 20:5n-3), docosapentaenoic acid (DPA; 22:5n-3), and docosahexaenoic acid (DHA; 22:6n-3) from fish and fish-oil supplements reduces disease risk factors, counters components of the metabolic syndrome including inflammation and high triglycerides, stabilizes heart cells, prevents blood clots from forming, and decreases all-cause mortality, cardiac and sudden death, and possibly stroke (Circulation 2006;114:82-96).
The health benefits of n3-PUFAs have prompted the U.S. Food and Drug Administration (FDA) to support a qualified health claim status for EPA and DHA. Estimates are that the ratio of omega-6 (n-6) linoleic acid (LA) to omega-3 (n-3) α-linolenic acid (ALA; 18:3n-3), ALA increased from 6.4 to 10.0 during the 20th century, resulting in decreased tissue concentrations of EPA and DHA (Am J Clin Nutr 2011;93:950-962). Recommendations for EPA and DHA intake vary, but in general, most organizations recommend a range of 300 to 1,000 mg/day from fatty fish and supplements (Circulation 2006;114:82-96). The FDA recommends that consumers not exceed 3,000 mg/day of EPA and DHA, with no more than 2,000 mg/day from a dietary supplement.
The persistent increase in inflammation biomarkers is defined as chronic or systemic inflammation, and is linked with multiple disorders and diseases including atherosclerosis and cardiovascular disease (CVD), the metabolic syndrome (MetS), and diabetes mellitus (Circulation 2003;107:499-511). C-reactive protein (CRP) is the most frequently measured inflammatory biomarker, and individuals with CRP values in the upper tertile of the adult population (>3.0 mg/L) have a 2-fold increase in CVD risk compared to those with a CRP concentration below 1.0 mg/L (Curr Atheroscler Rep 2010;12:110-8). An elevated fasting IL-6 concentration is a significant component of the chronic low-grade inflammation (Metabolism 2007;56:332-8). Epidemiological studies suggest an inverse relationship between CRP and a diet rich in marine products (Am J Clin Nutr 2006;84:223-9). At sufficiently high intakes, n-3 PUFAs may decrease the production of inflammatory eicosanoids and cytokines (Mol Nutr Food Res 2008;52:885-97). The majority of intervention studies in adults with features of MetS report a benefit for some inflammatory measures, but other studies using high n-3 fatty acid doses and long supplementation periods have reported no effect (for review, see Lipids 2013;48:319-32). A pre-existing inflammatory state or a poor n-3 PUFA status may be required to see a benefit of n-3 PUFAs on systemic inflammation.
Palmitoleic acid (C16:1 n-7) is an omega-7 monounsaturated fatty acid that is found in macadamia nuts and the seeds of a variety of plants including cat's claw, sea buckthorn, and milk weed (Prog Lipid Res 2012;51:340-9). Macadamia nuts are the only practical source for palmitoleic acid (30%). The nutritional and biological functions of palmitoleic acid are complex and scientific understanding of the biological significance on human health is limited (J Lipid Res 2011;52:808-12; Curr Opin Clin Nutr Metab Care. 2013;16:225-31). Palmitoleate may increase cell membrane fluidity, attenuate insulin resistance, and reduce inflammation associated with diabetes and heart disease (for review, see Prog Lipid Res 2012;51:340-9). Several human studies indicate that supplementation and/or inclusion of macadamia nuts in a cholesterol-lowering diet significantly reduces LDL-C concentrations (4.0-10.7%) and triglyceride concentrations (9.0-20.9%) (see J Nutr 2008;138:761-7; Arch Intern Med 2000;160:1154-8). One human study with 17 male hypercholesterolemia subjects showed that supplementation with macadamia nuts for a period of 4 weeks reduced plasma biomarkers for inflammation and oxidative stress (Lipids 2007;42:583-7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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-
- •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.
结局指标
主要结局
Change in systemic inflammation as measured with CRP and cytokines
时间窗: 8 weeks
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).
次要结局
- Change in plasma lipoproteins (cholesterol, triglycerides, LDL-chol, HDL-chol)(8 weeks)