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临床试验/NCT03561363
NCT03561363已完成不适用

The Effect of 6 Weeks Saturated and Polyunsaturated High-Fat Diets on Insulin Sensitivity and Health Parameters

University of Copenhagen0 个研究点目标入组 18 人开始时间: 2014年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
主要终点
Change in whole body and peripheral insulin sensitivity

研究概览

简要总结

The aim of the intervention is to gain insight into the long term effect of dietary fatty acid quality on insulin sensitivity and health parameters in healthy men.

Whole body and peripheral insulin sensitivity were measured, together with analyses of plasma hormones and metabolites. The plasma proteome was also analyzed. Molecular adaptations in skeletal muscle and adipose tissue were subject for investigation. Furthermore, gut microbiota population number and diversity will be analyzed from faeces samples obtained before and after the intervention.

详细描述

Two experimental diets with a high fat content (65 E% fat), enriched in either saturated or polyunsaturated fatty acids, were provided for 6 weeks to healthy men, in a randomized controlled intervention study with two arms.

Healthy, untrained, non-obese male subjects (27-45 years) were included in the study. The experimental diets are eucaloric, and thus provided so the subjects remains weight stable.

Before and after the intervention, two experimental days was conducted (2 experiments before and 2 experiments after the intervention).

At pre-intervention, subjects completed a high-fat meal test and insulin sensitivity was measured by the hyperinsulinemic-euglycemic clamp. On both days, blood and tissue biopsies were obtained. These two experimental days were repeated at the end of the 6 weeks intervention.

The hyperinsulinemic-euglycemic clamp was combined with stable isotope infusion (deuterium labelled glucose) in order to measure hepatic glucose production. Before the clamp, a catheter is inserted into the femoral vein, to enable measurement of insulin stimulated glucose uptake across the leg. Biopsies are obtained by the needle biopsy method from the vastus lateralis muscle and peri-umbilical subcutaneous adipose tissue. Blood samples were analyzed for glucose, insulin, inflammatory markers, gut hormones, adipokines, plasma fatty acid composition, and lipoprotein profile. Indirect calorimetric was also applied to measure substrate oxidation during the experimental days.

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
27 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy male subjects
  • 27-45 years
  • BMI 22-31
  • maximal oxygen uptake <48 ml/kg/min

排除标准

  • use of medication
  • parents with type-2 diabetes

研究组 & 干预措施

Saturated high-fat diet

Experimental

In this intervention group, subjects ingest a saturated eucaloric high-fat diet (64 E%) with total fat content being similar to the polyunsaturated high-fat diet.

The diet is enriched in saturated fat (36 E%). The main saturated fatty acids in the diet are primarily palmitic acid (C16:0) and stearic acid (C18:0). The main food sources are milk products, high-fat meat and vegetables.

Carbohydrate comprise 20 E% and protein 15 E%.

干预措施: High-fat diet (Behavioral)

polyunsaturated high-fat diet

Experimental

In this intervention group, subjects ingest a polyunsaturated eucaloric high-fat diet (64 E%), with total fat content being similar to the saturated high-fat diet. The diet is enriched in polyunsaturated fat (32 E%). The main polyunsaturated fatty acids in the diet are primarily linoleic acid (C18:2 n-6) and alpha-linoleic acid (C18:3 n-3). The main food sources are vegetable oils, nuts and high-fat fish (e.g. salmon). Carbohydrate comprise 20 E% and protein 15 E%.

干预措施: High-fat diet (Behavioral)

结局指标

主要结局

Change in whole body and peripheral insulin sensitivity

时间窗: Each subject completes a hyperinsulinemic-euglycemic clamp at pre-intervention (week 0) and again after 6 weeks of intervention.

This outcome will be evaluated with the hyperinsulinemic-euglycemic clamp, combined with the femoral arterio-venous balance technique

次要结局

  • Change in gut microbiota population number and diversity(Faeces samples are obtained from each subject at pre-intervention (week 0), and after the intervention (week 6). Analyses will be performed when the last faeces sample is obtained.)

研究者

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

Annemarie Lundsgaard

PostDoc. and principal investigator

University of Copenhagen

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