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临床试验/NCT02668159
NCT02668159已完成不适用

Cardiometabolic Health Effects and Mechanisms of Action of Fish Nutrients

Laval University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Serum glucose area under the curve (Glucose AUC)

研究概览

简要总结

The overall goal of this study is to investigate the effects and the mechanisms of action of a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to study the acute physiological effects of fish nutrients and to discover gene/metabolite networks that underlie these effects.

详细描述

Sedentary lifestyle and excess calorie intake have contributed to a dramatic increase in the occurrence of obesity, metabolic syndrome (MetS), type 2 diabetes (T2D) and cardiovascular disease (CVD) The first step in reducing the excessive CVD risk associated with the presence of the MetS is the adoption of a healthier lifestyle. A balanced diet, including high-nutritive and low-energy foods such as fish, is an important component of a healthy diet. Fish is a major source of n-3 PUFA, high-quality protein, and other essential nutrients such as vitamin D. Fish consumption may therefore improve the components of the MetS and reduce the incidence of T2D and CVD in obese subjects.The foundation of this project stems from the well-recognized fact that few Canadians meet the weekly dietary recommendation for fish consumption (i.e. 2 servings/week) and thus intakes of both n-3 polyunsaturated fatty acid (PUFA) and fish protein are low in the general population, and even lower in obese subjects. Since some people simply dislike fish and because certain types of fish contain toxic contaminants, including heavy metals and environmental pollutants, fish consumption remains low. Therefore, dietary choices limit intake of its key nutrients, thus increasing risk for MetS, T2D and CVD. Also, fish is one of the richest food sources of dietary vitamin D which may also contribute to the health benefits of fish consumption. Indeed, it is currently estimated that ∼40% of Canadians have low serum 25-hydroxyvitamin D [25(OH)D] concentrations (≤50 nM) and that ∼70% are below 75 nM. In addition, obesity is an important risk factor for low serum 25(OH)D.The main objective of this study is to investigate the acute effects and mechanisms of action of fish peptide and vitamin D on glucose metabolism, parameters of insulin sensibility and secretion, and cardiometabolic risk profile in overweight men.

A four-arm randomized crossover design will be used to test the metabolic effects of consuming prior to a 3h-oral glucose tolerance test (OGTT), supplements containing either fish peptide (3 grams), vitamin D3 (1000 IU), a combination of fish peptide + vitamin D3 or a placebo.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • overweight (BMI 25-40 kg/m2)
  • fasting triglycerides ≥ 1.5 mmol/L
  • fasting insulin ≥ 60 pmol/L
  • non-smoking
  • stable weight in the past 3 months

排除标准

  • chronic diseases
  • taking drugs that could affect glucose or lipid metabolism
  • taking dietary supplements or natural health products
  • major surgery 3 months prior to the study
  • fish or seafood allergy
  • lactose intolerance

结局指标

主要结局

Serum glucose area under the curve (Glucose AUC)

时间窗: 0-180 min

The area under the curve for serum glucose concentration is calculated from 0-180min after 75g glucose is ingested

次要结局

  • Serum insulin area under the curve (Insulin AUC)(0-180 min)
  • Serum 25(OH)D concentrations(4 weeks)
  • Serum C-peptide area under the curve (C-peptide AUC)(0-180 min)
  • Serum triglycerides concentrations(-15, 0, 15, 30, 60, 120, 180 min post 75g glucose)
  • Gene expression profile(4 weeks)
  • Cardiometabolic risk profile in serum(4 weeks)

研究者

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

Marie-Claude Vohl

Professor

Laval University

研究点 (2)

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