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临床试验/NCT03441620
NCT03441620已完成不适用

Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.

University of Nevada, Las Vegas6 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
6
主要终点
Serum Lipid profiles

研究概览

简要总结

In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study.

详细描述

The screen visit will involve an 8 hour fasting state and the following procedures:

  • Completing screening questionnaire
  • Measuring height, weight, blood pressure, and waist size
  • Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel All subjects will be asked to follow usual diet and lifestyle, and refrain from other sources of berries and related products while on the study. Subjects will also maintain 3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS facility for clinical research). Blood draws will be performed by trained phlebotomists (to be hired) at MPE 326, and all procedures will be performed by trained research personnel [PI &Co-PI: Basu, Izuora and graduate student]. In case of blood pressure, an average of at least three readings, 10 min apart, will be measured at each visit for each participant. Blood glucose (fasting and postprandial at two hours) will be determined at each time point. The oral glucose tolerance tests will be conducted at MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a standard and widely used formula in calculating insulin resistance based on fasting glucose values. Screening and follow-up tests will include clinical laboratory tests for blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine effects of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

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

入选标准

  • elevated total and LDL cholesterol (>116 mg/dL)
  • body mass index (> or = 30 kg/m2)
  • features of the metabolic syndrome

排除标准

  • taking glucose and lipid lowering medications (e.g. statins, metformin)
  • history of chronic conditions (diabetes, CHD, anemia, renal diseases)
  • allergic to strawberries
  • pregnant and/or lactating
  • vegetarian or consuming special diet

结局指标

主要结局

Serum Lipid profiles

时间窗: 14 weeks

Serum LDL, total and HDL cholesterol, triglycerides

Serum lipid particle concentrations

时间窗: 14 weeks

Molar concentrations of serum lipids and particle size

Glycemic control

时间窗: 14 weeks

Blood glucose

Diabetes control

时间窗: 14 weeks

Insulin resistance

次要结局

  • Systemic Inflammation(14 weeks)
  • Serum metabolomics(14 weeks)
  • Systemic Anthocyanins(14 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 (6)

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