Pilot: Combining Fish Oil and Exercise to Improve Obesity-Associated Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 120
- 主要终点
- Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 6 weeks
研究概览
简要总结
The goal of this pilot study is to understand the combined effects of fish oil and exercise in obesity-associated inflammation acutely. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and reduce inflammation and metabolic risk.
详细描述
Incidence of obesity continues to increase in the United States and worldwide, making its prevention or reduction a public health priority. Nutrition research that can lead to effective prevention strategies is greatly needed. Inflammation is a major underlying cause for obesity, and it is imperative that we understand how anti-inflammatory food sources, such as fish oil, could aid in reducing obesity. Moreover, exercise is effective at reducing systemic inflammation and improving insulin resistance. Both exercise and diet can influence health through changes in the gut microbiome; however, no studies have investigated how together these affect gut microbiome and overall metabolic health. The goal is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program reduce inflammation and metabolic risk. This study will provide the foundation for development of novel strategies for obesity, inflammation, dyslipidemia and dysglycemia.
Aim 1: Determine combined effects of n-3 PUFA and HIIT on improving metabolic risk:
The investigators will test the hypothesis that n-3 PUFA in addition to HIIT will have beneficial effects on obesity-related markers of inflammation, dyslipidemia and insulin resistance in placebo, n-3 or exercise alone, and combined n-3 and exercise.
Aim 1.1: Investigate the influence of n-3 PUFA and HIIT on body weight and composition:
At baseline (week 0), anthropometric assessments will be performed, including: (1) height (m); (2) weight (kg); (3) waist circumference (cm); (4) hip circumference (cm); and body composition which will be assessed utilizing dual-energy X-ray absorptiometry (DXA) scanning. Anthropometric measures will be repeated at post-intervention (week 6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old.
- •Overweight/ Obese.
- •Elevated Triglycerides.
- •Fasting blood glucose < 126 mg/dL
排除标准
- •Diagnosed with diabetes, liver disease, or any lower gastrointestinal disease.
- •Currently taking blood pressure, diabetes, or lipid lowering medication.
- •Received antibiotic treatment within the last 6 months.
- •Are pregnant, lactating, have an irregular menstrual cycle, or are menopausal.
- •Currently following a structured or formal weight loss program.
- •Exercise ≥ 1 time/week or a moderate-high score on the International Physical Activity Questionnaire.
- •Currently taking fish oil supplements (within 4 weeks prior to participant randomization) or eat ≥1 fatty fish meal/week.
- •Do not have access to a smartphone.
- •Feel uncomfortable riding a stationary bike for 30 minutes.
结局指标
主要结局
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 6 weeks
时间窗: Baseline and 6 weeks
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Total/HDL cholesterol at 6 weeks
时间窗: Baseline and 6 weeks
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Fasting blood glucose at 6 weeks
时间窗: Baseline and 6 weeks
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Interleukin (IL)-10 at 6 weeks
时间窗: Baseline and 6 weeks
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 6 weeks
时间窗: Baseline and 6 weeks
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in High-density lipoprotein (HDL) at 6 weeks
时间窗: Baseline and 6 weeks
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 6 weeks
时间窗: Baseline and 6 weeks
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 6 weeks
时间窗: Baseline and 6 weeks
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Baseline in Total cholesterol (mg/dL) at 6 weeks
时间窗: Baseline and 6 weeks
Total cholesterol (mg/dL)
Mean Change from Baseline in Tumor necrosis factor at 6 weeks
时间窗: Baseline and 6 weeks
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Interleukin (IL)-6 at 6 weeks
时间窗: Baseline and 6 weeks
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Triglycerides at 6 weeks
时间窗: Baseline and 6 weeks
Triglycerides (mg/dL).
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 6 weeks
时间窗: Baseline and 6 weeks
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Cardio Respiratory Fitness at week 0
时间窗: Baseline and 6 weeks
VO2 Max (mL/kg/min)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 6 weeks
时间窗: Baseline and 6 weeks
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Insulin at 6 weeks
时间窗: Baseline and 6 weeks
Insulin (μU/mL)
Mean Change from Baseline in Total Body Fat Percentage at 6 weeks
时间窗: Baseline and 6 weeks
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
次要结局
- Mean Change from Baseline in Butyrate Profile at 6 weeks(Baseline and 6 weeks)
- Mean Change from Baseline in Bacterial Profile at 6 weeks(Baseline and 6 weeks)
- Mean Change from Baseline in Serum Acetate Profile at 6 weeks(Baseline and 6 weeks)
- Mean Change from Baseline in Propionate Profile at 6 weeks(Baseline and 6 weeks)
研究者
Kembra Albracht
Assistant Professor
Texas Tech University