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临床试验/NCT02903433
NCT02903433已完成不适用

Effects of Avocado Intake on the Nutritional Status of Families

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年4月20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
72
试验地点
2
主要终点
Change in family energy consumption at 3 and 6 months

研究概览

简要总结

Avocados are an excellent source of fiber, potassium, magnesium, and poly- and mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns and have the potential to improve the cardiovascular disease (CVD) risk profiles of families in the United States (US). The proposed research plan will focus on the contribution of avocado intake to the reduction in CVD risk of US families, by examining the effects of avocado intake on the overall nutritional status of families. Of particular interest is establishing these effects in ethnic populations such as Hispanics/Latinos. On average, Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD. This 6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine the impact of avocados on the overall dietary pattern of their families. Future research will extend the results of the current trial to a larger sample of ethnically diverse families in order to evaluate whether sustained changes occur in nutritional, cardiovascular and metabolic health status.

详细描述

Specific Aim 1: To determine how avocados are incorporated into the family's dietary pattern and impact selected measures of nutritional status:

  1. To determine if avocado intake substitutes for, or adds to, other sources of calories in the family diet.
  2. To determine if avocado intake helps reduce between-meal snacking of family members.
  3. To determine if avocados help families meet US Dietary Guidelines for recommended intake of: poly- and monounsaturated fats; vegetables; fiber; selected nutrients (vitamins C, D and E, Folate, Calcium, Magnesium, potassium, iron); lutein and other carotenoids.

Specific aim 2: To determine if increased avocado intake affects cardio-metabolic risk factors to include lipids, glucose, insulin, and HbA1c.

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
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be part of a family that consists of at least 3 individuals, but no more than 8, who reside in the same home
  • Self-identify as Latino or Hispanic
  • Be older than 5 years of age

排除标准

  • Families with members who have clinically severe chronic diseases requiring specific diets (e.g. stage IV congestive heart failure, chronic kidney disease requiring dialysis)
  • Those allergic to avocados
  • Those with LATEX allergy
  • Families who are already high consumers of avocados (i.e. more than 1 avocado per adult and more than ½ avocado per child per day);
  • Those who are unwilling to eat avocados.
  • Family members with nursing or pregnant females or females planning to become pregnant
  • Family members under the age of 5 years will not be counted toward the number of family members who will be expected to participate in the intervention (i.e., adhere to healthy diet tips or consume avocados)
  • Families intending to move, or which include family members intending to move, within the next 6 months

结局指标

主要结局

Change in family energy consumption at 3 and 6 months

时间窗: 3 months and 6 months

Change in distribution of macro and micronutrient intake at 6 months

时间窗: 3 months and 6 months

次要结局

  • Change in cardio-metabolic risk factors by glucose at 6 months(3 months and 6 months)
  • Change in nutritional status by red blood cell magnesium at 6 months(3 months and 6 months)
  • Change in cardio-metabolic risk factors by insulin at 6 months(3 months and 6 months)
  • Change in cardio-metabolic risk factors by serum lipids at 6 months(3 months and 6 months)
  • Change in nutritional status by red blood cell fatty acid composition at 6 months(3 months and 6 months)
  • Change in nutritional status by serum total and fractionated carotenoids at 6 months(3 months and 6 months)
  • Change in cardio-metabolic risk factors by computation of homeostasis model assessment at 6 months(3 months and 6 months)

研究者

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

Matthew Allison

Primary Investigator

University of California, San Diego

研究点 (2)

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