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临床试验/NCT03935048
NCT03935048进行中(未招募)不适用

The Effect of a Higher Protein, Lower Glycemic Load Diet Containing Potato or Potato-based Products on Metabolic Health in Adults With Metabolic Syndrome

University of Arkansas, Fayetteville2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
2
主要终点
Plasma glucose levels

研究概览

简要总结

The prevalence of US adults with Metabolic Syndrome (MetS) is over 34%, impacting nearly 35% of all adults and 50% of those aged 60 years or older. MetS is characterized as a combination of underlying risk factors that when, occurring together, increase the risk for chronic diseases such as type 2 diabetes mellitus (T2DM), cardiovascular disease, stroke, and certain types of cancer, resulting in an 1.6-fold increase in mortality. According the American Heart Association, health risks associated with Metabolic Syndrome can be significantly reduced by reducing body weight and eating a diet that is rich in whole grains, fruits, and vegetables. Potatoes (e.g. skin-on white potatoes) are an excellent source of potassium, vitamin C, and vitamin B6 and a good source of magnesium and dietary fiber. In addition, the potato has greater dry matter and protein per unit growing area compared with cereals. Despite this, consumers tend to believe that potatoes are high in calories and in fat compared with other carbohydrate sources such as rice or pasta, an incorrect assumption since a potato has negligible fat and a low energy density similar to legumes. Data from short-term nutrition intervention trials, suggest that potatoes consumed as part of a low-glycemic load meal can play a role in the prevention or treatment of MetS. However, the impact of long-term potato consumption on cardiometabolic risk factors associated with MetS is not known. Therefore, there is a critical need to determine if regular (> 4 times per week) potato consumption can improve cardiometabolic health in individuals with MetS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resides in Northwest Arkansas
  • Age 18+ years
  • Metabolic Syndrome (characterized by participant having three or more of the following measurements: abdominal obesity, triglyceride level over 150 mg/dl, HDL cholesterol < 40 mg/dl in men and 50 mg/dl in women, systolic blood pressure of 130 mm Hg or diastolic blood pressure of 85 mm Hg, and/or fasting glucose > 100 mg/dL)
  • All ethnicities
  • Female and male
  • Currently consuming a high glycemic load diet

排除标准

  • Food allergies
  • Dietary restrictions (e.g. vegetarian, vegan, etc.)
  • Trying to lose weight in last 3 months
  • Prescription medications related to heart disease or type 2 diabetes
  • Fear of needles

结局指标

主要结局

Plasma glucose levels

时间窗: Change from baseline at 16 weeks

Plasma glucose levels

Serum lipid levels

时间窗: Change from baseline at 16 weeks

Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Free Fatty Acids, Triglycerides

次要结局

  • Dietary intake(Change of time of study (16 weeks))
  • Mood(Change from baseline at 16 weeks)
  • Waist circumference(Change from baseline at 16 weeks)
  • Sleep duration(Change from baseline at 16 weeks)
  • Sleep quality and duration(Change from baseline at 16 weeks)
  • Marker of appetite and sleep(Change from baseline at 16 weeks)
  • Appetite(Change from baseline at 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie Baum

Associate Professor

University of Arkansas, Fayetteville

研究点 (2)

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