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临床试验/NCT07732816
NCT07732816已完成不适用

Effect of an Eight Week Dietary Intervention of Pecans on Cardiometabolic Parameters and Serum Cytokines in Individuals With Obesity or Overweight

Viterbo University0 个研究点目标入组 22 人开始时间: 2016年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
主要终点
body composition

研究概览

简要总结

You are invited to participate in a research study being conducted by Karen Gibson, Maria Morgan-Bathke, Dana Swope, Grace Huebner, Rebecca Brannan, Samuel McCormick at Viterbo University. The purpose of this research is to determine the effectiveness of using nuts and avocados as a dietary intervention on improving fasting blood glucose, lipid profile, energy expenditure, and body composition on pre-diabetic individuals compared to a control group. We hope to learn if a dietary intervention of nuts or avocado can help improve blood sugar, lipid panel and/or body composition. You were selected as a possible participant in this study because you have been diagnosed with pre-diabetes. If you decide to participate, you will be asked to complete an initial two hour appointment, follow the protocol of one of the interventions (one avocado or 1 ½ ounce nuts) and control group with only dietary counseling provided) daily for an eight week period, weekly telephone and/or email nutrition counseling, and attend a final two hour appointment. The food for the intervention (avocados and nuts) will be provided by the researchers and will not need to be purchased by the participants. The initial and final two hour appointments will consist of the following measurements: An overnight fast, blood glucose, cytokine level, and lipid panel tests will be completed by a venous blood draw. Then Maltron scan (to measure body composition, which in non-invasive and uses electrodes on the skin), waist/hip measurements, height/weight, and VioCare food frequency questionnaire will be completed. Following these screening measurements, a COSMED test to determine resting energy expenditure (REE) will be measured.

It may take approximately 10 weeks from beginning to completion of this study.

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
None

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

  • - BMI of 25.0-40.0

排除标准

  • BMI below 25.0 or over 40.0
  • anyone who works a 3rd shift
  • pregnant and breastfeeding women
  • those with pre-existing chronic conditions
  • those with a latex allergy

结局指标

主要结局

body composition

时间窗: 10 weeks

percentage body fat

fasting blood glucose

时间窗: 10 weeks

fasting blood glucose in mg/dl

weight

时间窗: 10 weeks

weight in kg

height

时间窗: 10 weeks

height in meters

total cholesterol

时间窗: 10 weeks

total cholesterol in mg/dl

LDL cholesterol

时间窗: 10 weeks

LDL cholesterol in mg/dl

HDL

时间窗: 10 weeks

HDL cholesterol in mg/dl

TG

时间窗: 10 weeks

triglycerides in mg/dl

次要结局

  • inflammation(10 weeks)
  • anti-inflammatory(10 weeks)

研究者

发起方
Viterbo University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Morgan-Bathke

Associate Professor

Viterbo University

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