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临床试验/NCT02647970
NCT02647970已完成不适用

Stearoyl-CoA Desaturase and Energy Metabolism in Humans

University of Oslo1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年2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
14
试验地点
1
主要终点
Change in metabolic biomarkers

研究概览

简要总结

The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1) activity through dietary interventions can increase energy metabolism in humans.

详细描述

In rodents as well as humans, high stearoyl-coenzyme A desaturase-1 (SCD1) activity is considered to be involved in development of obesity. In animal models, polyunsaturated fatty acids (PUFA) inhibit Scd1 gene expression and at the population level, dietary PUFA and plasma PUFA show strong inverse associations with plasma SCD indices. Emerging evidence also suggests a role for the sulphur amino acid cysteine in regulating SCD1 activity and obesity.

The overall aim of the project is to examine if interventions that lowers SCD1 activity lead to increased energy metabolism. In this project, the investigators will conduct dietary intervention trials to evaluate the effects of short-term consumption of a diet rich in polyunsaturated fatty acids (PUFA) and low in cysteine and its precursor methionine (PUFA-Cys/Met) vs. a diet rich in saturated fatty acids (SFA) and cysteine/methionine (SFA+Cys/Met) on SCD1 activity, lipids, amino acids, glucose and other biomarkers related to energy metabolism, in healthy normal-weight subjects. Healthy volunteers will be randomized to the PUFA-Cys/Met or SFA+Cys/Met diets receiving supplements/meals in a single dose or for 7 days.

This study is a pilot study, with main focus on feasibility, tolerance and side effects. If the pilot shows positive results in terms of side effects, safety and tolerance, the investigators will follow-up by including obese subjects in a longer dietary intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Healthy normal-weight (BMI 20-25 kg/m2)
  • Exclusion Criteria
  • High physical activity
  • High intake of fatty fish or cod liver oil
  • Pregnancy or breastfeeding
  • Chronic disease

排除标准

  • 未提供

研究组 & 干预措施

Group B

Active Comparator

Dietary intervention

干预措施: SFA+Cys/Met diet (Behavioral)

Group A

Experimental

Dietary intervention

干预措施: PUFA-Cys/Met diet (Behavioral)

结局指标

主要结局

Change in metabolic biomarkers

时间窗: 0 hour and at 30 min, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after single meal. Baseline and up to 7 days in 7 days intervention

Measurement of biomarkers of amino acid and fatty acid metabolism, including plasma concentration of cysteine, methionine, fatty acids, and stearoyl CoA desaturase (SCD) indices

次要结局

  • Change in biomarkers of glucose metabolism(Baseline and up to 7 days)
  • Change in molecular signatures(Baseline and up to 7 days)
  • Appetite assessed by visual analogue scales(0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially (single meal intervention). Change from baseline up to 7 days (7 days intervention))
  • Change in inflammatory markers(Baseline and up to 7 days)
  • Feasibility and compliance of the diet intervention(Up to 7 days)
  • Tolerance of the diet intervention(Up to 7 days)
  • Change in biomarkers of triglycerides metabolism(Baseline and up to 7 days)
  • Hunger and satiety patterns(Baseline and up to 7 days)

研究者

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

Kathrine Vinknes

PhD

University of Oslo

研究点 (1)

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