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临床试验/NCT05362968
NCT05362968已完成1 期

Strawberries and Risk of Diabetes in Adults

University of Nevada, Las Vegas1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
39
试验地点
1
主要终点
Glycemic control

研究概览

简要总结

Strawberries can be categorized as a functional food based on results from several clinical trials in improving cardiometabolic health beyond providing nutrition. Recent studies identify the role of strawberries in improving insulin resistance and risks of type 2 diabetes which urgently warrants further investigation, keeping in view the huge public health burden of diabetes in the US. In this study, the investigators propose to investigate the effects of a dietary achievable dose of strawberries on glycemic control, insulin resistance, and HbA1c (primary variables) and biomarkers of inflammation and endothelial function in a 28- week controlled crossover study.

详细描述

Strawberries are popularly consumed fruits in the US and are a rich source of several bioactive compounds with demonstrated health benefits in T2D and cardiovascular disease (CVD). Based on previously reported studies, strawberries have been shown to improve elevated lipid profiles/dyslipidemia, oxidative stress and inflammation in adults with the metabolic syndrome or prediabetes. In a recently reported study, strawberries at a dose of two-and-a-half servings per day for four weeks was shown to significantly reduce insulin resistance and serum adipokines in obese adults. These results conform to only a few reported trials using strawberries in adults with cardiometabolic risks. While these study findings are clinically meaningful, these warrant urgent investigation in trials of longer duration specifically targeting adults with impaired fasting glucose (vs. other features of the metabolic syndrome) as well as adults with diagnosed T2D with poor glycemic control despite taking medications. Furthermore, to the best of our knowledge, only one clinical trial has been reported on the role of strawberries in improving glycemic control, oxidative stress, and inflammation in adults with T2D. While these results are encouraging, they lack generalizability due to the short duration of the study (six weeks) that precludes accurate changes in glycated hemoglobin (HbA1c) as a stable biomarker of glucose control. Based on these gaps in the existing literature, the investigators will examine the effects of strawberry supplementation at a dose of 2.5 servings/day for 12 weeks on glycemic control and related cardiometabolic profiles in prediabetes in a randomized controlled crossover trial.

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
Double (Investigator, Outcomes Assessor)

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

  • At least 18 years of age
  • Waist size greater than 40 inches in men or 35 inches in women
  • Blood glucose greater than 100mg/dL but less than 126 mg/dL or glycated hemoglobin less than 6.5%
  • Insulin resistance >1.0
  • Not on diabetes medications
  • Normal liver and kidney function tests

排除标准

  • Allergy to strawberries
  • Smoke or drink alcohol on a regular basis
  • Pregnant or lactating

研究组 & 干预措施

Strawberry intervention

Experimental

Each participants will consume freeze-dried strawberry powder (32g/day) for 12 weeks

干预措施: Freeze-dried strawberry powder (Drug)

结局指标

主要结局

Glycemic control

时间窗: 12 weeks

Blood glucose, insulin, glycated hemoglobin

Lipid control

时间窗: 12 weeks

Blood total and LDL cholesterol

次要结局

  • Inflammation(12 weeks)
  • Diabetes risk hormones(12 weeks)
  • Oxidative stress(12 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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