Highbush Blueberries, the DNA-damage of Obesity, Somatic Mutations and Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- DNA damage in peripheral blood mononuclear cells
研究概览
简要总结
Obesity usually brings with it disturbances in the body that increase the chances of developing serious diseases like diabetes and cancer. These disturbances include one or more symptoms of a condition called "metabolic syndrome" that often leads to diabetes. High levels of damage to the DNA that makes up our chromosomes have also been observed in obese people. It is possible that these two disturbances are connected. The goal of this project is to test this whether consumption of blueberries will improve these abnormalities.
详细描述
Unbalanced diets rich in refined carbohydrate calories, saturated fats, and trans fats, but low in vitamins, minerals, fiber, polyphenolics and ω-3 fatty acids are common in the United States, particularly among the obese. Insulin resistance and high levels of DNA damage commonly accompany obesity. There also appears to be a relationship between oxidative DNA-damage and biomarkers that characterize metabolic syndrome. The bioactivity of blueberries is usually attributed to their high content of polyphenolics which can reduce oxidative DNA damage. Since oxidative damage to mitochondrial DNA is a suggested causal factor leading to increased insulin resistance, we will test if blueberry consumption can be an ameliorative dietary factor for insulin resistance as well. If blueberry consumption both shifts metabolism away from insulin resistance and reduces DNA damage, it may be a useful tool to assist in understanding relationships between these two obesity-associated conditions.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-60 years;
- •Blood pressure <140/90 mmHg without antihypertensive medicines or with a stable dose of antihypertensive medicines (no change in last 3 months).;
- •Insulin resistance (HOMA/IR) > 2.0;
- •Willing to restrict intake of high polyphenol-containing foods during the trial period;
- •Willing to forego intake of nutritional supplements other than a multivitamin;
- •Willing to maintain their current daily level of exercise throughout the study.
排除标准
- •Known diabetes mellitus according to the 2013 ADA criteria;
- •Medications known to affect glucose metabolism;
- •Weight loss pharmacotherapy;
- •Lipid-lowering medication;
- •Untreated thyroid or chronic liver, renal, or cardiovascular disease;
- •Pregnancy- a negative urine pregnancy test will be documented for any women participants of childbearing age prior to enrollment.
- •History of allergic reactions to blueberries.
- •Any pathological condition known to alter white blood cell count over the previous 6 months;
- •Exposure to drugs known to cause mutations or radiation within the previous 6 months;
- •Alcohol consumption greater than 2 drinks/d for males and 1 drink/d for females.
研究组 & 干预措施
Blueberry Powder
The intervention group will receive the Blueberry freeze-dried powder equivalent to 1 cup of whole Blueberries twice a day for 8 weeks (i.e. 2 cups/day).
干预措施: Blueberry Powder (Dietary Supplement)
Placebo Powder
The placebo group will receive placebo powder in the same amounts for the same duration.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
DNA damage in peripheral blood mononuclear cells
时间窗: Baseline and 2 months
DNA double-stranded breaks (DSBs) will be measured.
次要结局
- Insulin resistance(Baseline and 2 months)