BioBehavioral Studies of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 2
- 主要终点
- Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Paced Respiration
研究概览
简要总结
Omega-3 fatty acids are a certain kind of fish fat that has recently been shown to have health benefits. This study will examine the effectiveness of fish oil supplementation for reducing the early signs of heart disease risk and for improving mood, impulsivity, and anger levels.
详细描述
Cardiovascular disease (CVD) is a broad term that includes diseases that affect the heart and blood vessels, including coronary heart disease, heart failure, high blood pressure, stroke and vascular dementia. CVD is the leading cause of death in the United States, resulting in 700,000 deaths each year. Preliminary research has shown that increased consumption of fish, specifically the omega-3 fatty acids found in fish oil, has beneficial effects in people with CVD. Fish oil may also have positive effects on the psychological health and well-being of people with psychiatric disorders. However, more research is needed to confirm the positive physical and psychological effects of fish oil in healthy adults. The purpose of this study is to explore potentail effects of fish oil supplementation on CVD mechanisms and risk markers, and on depressive symptoms, antagonistic disposition, and levels of impulsivity and aggression.
This study will enroll healthy adults who habitually consume low quantities of long-chain omega-3 fatty acids. Participants will be randomly assigned to receive either fish oil supplements or placebo on a daily basis for 4 months. Study visits will occur at baseline and Months 2 and 4. At the baseline and Month 4 visits, participants will undergo the following measures as primary study aims: blood collection for inflammatory markers; heart rate and variability measurements; and interviews, psychological tests, and questionnaires to assess mood, disposition, impulsivity, and aggression.
As secondary aims, we will test for any effects of fish oil on cognitive performance and, if a main effect on inflammatory markers is found, we will test for moderation by select genetic polymorphisms.
As an exploratory aim, we will test for any effects of fish oil on structural or functional brain imaging. (This exploratory aim was mistakenly listed as a secondary aim at the time of trial registration.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently employed at least 25 hours a week, but does not regularly work the third shift (i.e., night shift)
- •English is primary language
- •Consumes less than 300 mg/day of long-chain omega-3 fatty acids.
排除标准
- •Serious allergy to fish (e.g., anaphylaxis, bronchospasm, serious skin reaction)
- •History of atherosclerotic disease (e.g., myocardial infarction) or treatment of angina or claudication (e.g., angioplasty)
- •Reported history of schizophrenia or bipolar disorder
- •Long-term hepatitis
- •Kidney failure
- •Stroke or other neurological disorder
- •Lung disease requiring drug treatment
- •Stage 2 high blood pressure, defined as systolic blood pressure of 160 mm Hg or greater and diastolic blood pressure of 100 mm Hg or greater
- •Alcohol consumption of more than five drinks per day each week (i.e., more than 35 alcoholic drinks each week)
- •Pregnant or breastfeeding
- •Currently taking any cardiovascular, psychotropic, glucocorticoid, lipid-lowering, insulin, or weight loss medications
- •Currently taking fish oil supplements
结局指标
主要结局
Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Paced Respiration
时间窗: baseline and month 4
Mean successive difference in inter-beat intervals natural log transformed paced respiration in milliseconds
Type A, Total Score
时间窗: baseline and month 4
Structured Interview - Type A Behavior Pattern using the Interpersonal Hostility Assessment Technique (IHAT). The minimum value is 0, and the maximum value is 12. A higher score suggests a worse outcome.
Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration
时间窗: baseline and month 4
Total power (0 to .40 Hz) heart rate variability natural log transformed paced respiration in Hertz (Hz) units.
C-reactive Protein (CRP)
时间窗: baseline and month 4
fasting serum C-reactive protein (CRP) in milligrams per liter (mg/L)
Negative Affect
时间窗: baseline and month 4
Negative affect questions adapted from the Positive and Negative Affect Schedule - Expanded Form administered via ecological momentary assessment. The minimum value is 1, and the maximum value is 6. A higher score are worse (more negative affect).
Hostility, Barefoot Score
时间窗: baseline and month 4
The 27-item Barefoot Hostility Scale. The minimum value is 1, and the maximum value is 30. A higher score suggests a worse outcome.
Trait Anger
时间窗: baseline and month 4
State-Trait Anger Expression Inventory. The minimum value is 10, and the maximum value is 40. A higher score suggests a worse outcome.
High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Paced Respiration
时间窗: baseline and month 4
High frequency (.12 to .40 Hz) heart rate variability natural log transformed paced respiration in Hertz units (Hz)
Impulsivity
时间窗: baseline and month 4
Barratt Impulsiveness Scale. The minimum value is 34, and the maximum value is 120. A higher score suggests a worse outcome.
Anger Expression
时间窗: baseline and month 4
State-Trait Anger Expression Inventory. The minimum value is 0, and the maximum value is 72. A higher score suggests a worse outcome.
Circulating Serum Interleukin-6 (IL-6)
时间窗: Baseline and Month 4
Systemic inflammation: fasting serum Interleukin-6 (IL-6)
Aggression
时间窗: baseline and month 4
Bus-Perry Aggression Questionnaire. The minimum value is 14, and the maximum value is 53. A higher score suggests a worse outcome.
Total Power (0 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration
时间窗: baseline and month 4
Total power (0 to .40 Hz) heart rate variability natural log transformed unpaced respiration in Hertz (Hz) units
Mean Successive Difference in Inter-beat Intervals Natural Log Transformed Unpaced Respiration
时间窗: baseline and month 4
Mean successive difference in inter-beat intervals natural log transformed unpaced respiration in milliseconds (msec)
High Frequency (.12 to .40 Hz) Heart Rate Variability Natural Log Transformed Unpaced Respiration
时间窗: baseline and month 4
High frequency (.12 to .40 Hz) heart rate variability natural log transformed unpaced respiration in Hertz (Hz) units
次要结局
- Fluid Intelligence(Baseline and Month 4)
- Executive Function(Baseline and Month 4)
- Learning / Episodic Memory(Baseline and Month 4)
- Psychomotor Speed(Baseline and Month 4)
- Moderation of Effects of Fish Oil on Inflammatory Markers by Select Genetic Polymorphisms(Measured at Month 4)
研究者
Stephen Manuck
Professor
University of Pittsburgh