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临床试验/NCT03969264
NCT03969264已完成不适用

Tree Nut Consumption to Reduce Abdominal Adiposity and Risk for Metabolic Syndrome in Millennials

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年7月15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
84
试验地点
2
主要终点
Waist circumference

研究概览

简要总结

A major contributing factor to the rising waist circumference of U.S. young adults is the increase in snacking behavior. Both the frequency of snacking during the day and the percentage of adults who engage in snacking has risen; national data indicates snacking comprises 15-25% of the total daily caloric intake of young and middle-aged adults. The overarching hypothesis, based on significant preliminary data, is that the quantity and metabolic function of abdominal fat is a key intermediary factor by which greater tree nut consumption reduces ectopic lipid storage (including the accumulation of intra-abdominal [visceral] fat), improves fatty acid and lipoprotein metabolism, reduces systemic inflammation and insulin resistance, and thus, reduces risk for MetS in millennial-generation age individuals.

详细描述

A major contributing factor to the rising waist circumference of U.S. young adults is the increase in snacking behavior. Both the frequency of snacking during the day and the percentage of adults who engage in snacking has risen; national data indicates snacking comprises 15-25% of the total daily caloric intake of young and middle-aged adults. Unfortunately, current typical snack items are energy rich, providing high intake of carbohydrates and sugars, as opposed to nuts that are nutrient rich. In prior work with middle-aged adults, the investigators found that consuming tree nuts daily as between-meal snacks for a period of 16 weeks significantly reduced intra-abdominal (visceral) fat and waist circumference, which was associated with altered plasma fatty acid profiles and higher fatty acid oxidation rates. Based on prior findings, the investigators propose to determine whether consuming mixed tree nuts as replacement for typical high carbohydrate snacks reduces abdominal obesity and waist circumference in millennials at risk for MetS. The overarching hypothesis, based on significant preliminary data, is that the quantity and metabolic function of abdominal fat is a key intermediary factor by which greater tree nut consumption reduces ectopic lipid storage (including the accumulation of intra-abdominal [visceral] fat), improves fatty acid and lipoprotein metabolism, reduces systemic inflammation and insulin resistance, and thus, reduces risk for MetS in millennial-generation age individuals. The hypothesis will be tested by determining: 1) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on waist circumference and the quantity of abdominal fat (subcutaneous and visceral fat); 2) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on circulating fatty acid profiles, glucose tolerance and insulin resistance, circulating lipids and lipoproteins, and circulating markers of inflammation; and 3) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on abdominal tissue expression of genes that regulate inflammation, insulin resistance, and cardiometabolic mediators of MetS risk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Investigator and research assistant are blinded to study intervention.

入排标准

年龄范围
22 Years 至 36 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 22-36 years
  • BMI 18.5 to 34.9
  • At least one risk factor for metabolic syndrome based on waist circumference, HDL level or triglyceride level

排除标准

  • Tree nut allergy
  • Diagnosed chronic disease
  • Medication for dyslipidemia or hypertension
  • Weight loss medication
  • Narcotic medication or illicit drug use
  • Pregnancy or lactation or postmenopausal

结局指标

主要结局

Waist circumference

时间窗: 18 weeks

Change in waist circumference (in centimeters)

Visceral Fat

时间窗: 18 weeks

Change in quantity of intra-abdominal fat by CT scan

次要结局

  • Gene Expression in Adipose Tissue(18 weeks)
  • Glucose(18 weeks)
  • Inflammation(18 weeks)
  • Dietary Macronutrient Intake(18 weeks)
  • Insulin(18 weeks)

研究者

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

Heidi J. Silver

Research Associate Professor

Vanderbilt University Medical Center

研究点 (2)

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