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临床试验/NCT04841460
NCT04841460已完成不适用

Impact of Beef's Unique Food Matrix on Human Health - Cholesterol Metabolism and Voluntary Nutrient Intake in Men Consuming Low-fat and High-fat Ground Beef

Texas A&M University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年2月18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
25
试验地点
2
主要终点
Lipoprotein cholesterol

研究概览

简要总结

The primary goal of the proposed research is to document changes in plasma lipoprotein fractions, including high-density lipoprotein (HDL) and low-density lipoprotein (LDL) particle sizes and functionality, following the ground beef interventions. This specifically addresses the hypothesis that increasing the amount of fat in ground beef reduces risk factors for cardiovascular disease. Also, the investigators will measure changes in glucose, insulin, and triacylglycerols (TAG) following low-fat and high-fat ground beef interventions. An important aspect of this research is that the investigators will confirm that consumption of high-fat ground beef will reduce carbohydrate intake and increase insulin sensitivity in men. Furthermore, the investigators will be able to establish which protein sources are voluntarily replaced by the low- and high-fat ground beefs.

详细描述

Healthy, non-smoking males will be screened for eligibility, and a minimum of 30 males will be selected for the study based primarily on plasma low-density lipoprotein cholesterol (LDL-C) concentrations but also on plasma TAG concentrations. The men must not be consuming restrictive diets or cholesterol-lowering medications, and must not have total cholesterol above 300 mg/dL or below 120 mg/dL. Participants will be requested not to change their habitual level of physical activity. Plasma TAG should not exceed 220 mg/dL. A two-period, randomized cross-over design will be used based on previous studies from our laboratory. Each participant will complete two, 5-week ground beef interventions in a randomly assigned order with a 4-week washout period between the test periods. The men will consume 5 ground beef patties per week for 5 weeks for each ground beef type (25 patties for each type). The two treatments will be low-fat (5% fat) and high-fat (25% fat) ground beef. Participants will be assigned to one of two groups (n ≥ 15 per group), which will be balanced with regard to LDL-C concentrations at the initial screening. The groups will be blocked for age and body weight.

Visit 1 for the subjects selected for the study (immediately before the first dietary intervention) (about 1 hour):

The Registered Dietitian will provide diet instructions, sample menus and cooking instructions. Participants will receive instructions for completion of the diet records using the NutriBase software.

Participants will receive the first set of patties. Subjects will complete a 3-day diet record in NutriBase (which is done at home) before they begin eating the patties. Instructions will also be provided to subjects regarding schedule of patty consumption.

Subjects will complete a 3-day diet record in NutriBase during week 5 of the patty consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participant identities were coded and treatments were blinded.

入排标准

性别
Male
接受健康志愿者

入选标准

  • The participants will be male and not have had total cholesterol above 300 mg/dL or below 120 mg/dL.

排除标准

  • The participants will be male and must not have been consuming restrictive diets or cholesterol-lowering medications.

结局指标

主要结局

Lipoprotein cholesterol

时间窗: 10 weeks

Lipoprotein cholesterol concentrations and density distributions

次要结局

  • Body mass index(10 weeks)
  • Dietary intake(10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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