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临床试验/NCT02659748
NCT02659748Unknown不适用

Examining the Effects of Consuming a Diet Comprising of Milk Fat on Metabolic Health Markers

University of Vermont Medical Center2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
21
试验地点
2
主要终点
Insulin sensitivity

研究概览

简要总结

This study investigates the effects of bioactive fatty acids in full fat dairy (whole yogurt), on insulin action, calorie needs, blood lipids, immune function, and body composition in normal and overweight male and female volunteers.

详细描述

Saturated fats impair the action of insulin leading to abnormally high blood sugar levels that are characteristic of diabetes. Since milk fat is high in saturated fat, some experts advise against whole dairy products (e.g., milk and yogurt). However, bioactive fats, such as those which occur in milk fat, may be beneficial in the prevention of diabetes.

Current data provide no compelling evidence that a moderate intake of saturated fat from milk fat increases the risk of diabetes. Milk fat contains a unique variety of bioactive fats, which may be beneficial and may counterbalance the potential negative effects of saturated fat.

The investigators hypothesize that milk fat has favorable effects on metabolic risk markers associated with the metabolic syndrome. Therefore, this study tests the hypothesis that milk-fat intake will:

(i) result in improved insulin sensitivity,

(ii) favorably alter postprandial lipid metabolism, and

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health and not expecting major lifestyle changes while on study
  • BMI between 18.5 and 29.9 kg/m2
  • Willing to follow the study coordinator's and dietitian's instructions

排除标准

  • Subject with any chronic disease, inflammatory disease and previous diagnosis of HIV or hepatitis C
  • Subjects with diabetes (type 1 or 2)
  • Subjects with insulin resistance
  • Subjects who manifest metabolic syndrome based on aggregate clinical signs
  • Intolerance to dairy foods
  • Use of prescription medication (except oral contraceptives)
  • On medically prescribed diets or following a diet
  • Taking supplements that could obscure our ability to detect diet effects
  • Frequent use of over-the-counter medication
  • Habitual use of tobacco or controlled substances such as cannabis
  • Low-density lipoprotein cholesterol (LDL-C) or triacylglycerol (TAG) concentrations <5th or >95th percentile for age
  • Participation on regular basis in competitive sports or habitual aerobic exercise training, which we will arbitrarily define as consisting of > 3 bouts/wk of aerobic exercise (unable to speak comfortably) for more than 20 min
  • Women who are pregnant or lactating or planning to get pregnant
  • Allergies or significant food preferences or restrictions that would interfere with diet adherence
  • Lifestyle or schedule incompatible with the study protocol
  • Psychiatric or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol
  • Heart condition

结局指标

主要结局

Insulin sensitivity

时间窗: 3 weeks

Determined via a frequently sampled intravenous glucose tolerance test (FSIVGTT). Serum samples are analyzed in-house (glucose: glucose oxidase method; insulin: ELISA) to be used in Bergman's minimal model analysis. The results will be used to estimate insulin sensitivity.

次要结局

  • Inflammation markers.(3 weeks)
  • Blood lipids(3 weeks)
  • Serum phospholipid analysis(3 weeks)
  • Bacterial microbiota(3 weeks)

研究者

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

Jana Kraft

Assistant Professor

University of Vermont

研究点 (2)

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