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临床试验/NCT03467503
NCT03467503已完成不适用

Healthy Diet for Healthy Moms and Babies

University of Nevada, Las Vegas1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Gestational weight gain

研究概览

简要总结

The purpose of this clinical study is to collect baseline information on dietary habits and metabolic risk factors, and to examine the effects of a dietary intervention focusing on fiber and antioxidant rich berries on the development of gestational diabetes, maternal glucose and lipid control and inflammation in obese pregnant women at risk of developing diabetes. With the ongoing epidemic of obesity, the prevalence of gestational diabetes is significantly increasing and the goal of this research is to identify optimal dietary strategies that can reverse this condition or control the rise in blood glucose among those with already developed diabetes.

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
Single (Care Provider)

入排标准

年龄范围
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •BMI > or = 30, <20 weeks gestation and singleton pregnancy with the following options: previous history of gestational diabetes and/or family history of diabetes

排除标准

  • •• Twin or multiple pregnancy
  • •Chronic pre-pregnancy conditions (CHD, cancer, diabetes)
  • •Gastrointestinal conditions
  • •Allergic to berries and fiber
  • •Vegetarian food habits or special diets
  • •Not proficient in English and/or unable to provide consent

研究组 & 干预措施

Prenatal Care/Nutrition Education

No Intervention

Participants were given nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.

Dietary Intervention

Experimental

Participants were given dietary blueberries (2 cups) and soluble fiber (12g). They also received nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.

干预措施: Blueberry + soluble fiber (Dietary Supplement)

结局指标

主要结局

Gestational weight gain

时间窗: 20 weeks

Maternal weight gain in lbs

Maternal inflammation

时间窗: 20 weeks

C-reactive protein as a stable biomarker of inflammation

Gestational glycemia

时间窗: 20 weeks

Maternal blood glucose and HbA1c as measures of glycemia

Maternal serum lipids

时间窗: 20 weeks

Conventional total, LDL-cholesterol and their particle size to describe lipid profiles

次要结局

  • Maternal dietary intakes(20 weeks)
  • Maternal biomarkers of atherosclerosis(20 weeks)

研究者

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

Arpita Basu

Associate Professor

University of Nevada, Las Vegas

研究点 (1)

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