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临床试验/NCT06364163
NCT06364163进行中(未招募)不适用

A Study on the Effect of Consuming a Herring Oil Concentrate on LDL Cholesterol Concentration in Adults With Overweight or Obesity

University of Bergen1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Serum concentration of LDL-cholesterol

研究概览

简要总结

High cholesterol concentration is a major risk factor for cardiovascular disease (CVD), and consumption of fish has been associated with a lower CVD risk in several studies. The beneficial health effects of consuming fish have traditionally been ascribed to the long-chain PUFA (LC-PUFA) EPA (C20:5n-3) and DHA (C22:6n-3), although consumption of fish oils or concentrates with high EPA and DHA contents does not affect the cholesterol concentration in humans and lowers the cholesterol concentration in rats and mice only when given in very high doses. Fish oils contain a plethora of fatty acids besides EPA and DHA, and in recent years, increased focus has been on the long-chain MUFA (LC-MUFA) cetoleic acid (C22:1n-11). Cetoleic acid is found in high amounts in oils from certain fish species such as herring, which has relatively low contents of both EPA and DHA. The investigators have recently summarised and meta-analysed the available literature that investigates the effects of diets containing fish oils or fish oil concentrates that have a high content of cetoleic acid but low or no content of EPA and DHA on cholesterol concentration in rodents, showing that cetoleic acid-rich fish oils and concentrates prevent high cholesterol concentration.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • BMI over 25 kg/m2
  • Stable body weight last 3 months

排除标准

  • Allergies towards fish, milk, egg, gluten
  • Tobacco use (cigarettes or snus)
  • Diseases affecting the heart, intestinal function, kidney function or insulin secretion
  • Use of medications targeting cholesterol -or glucose metabolism
  • Use of dietary supplements
  • Pregnant or breastfeeding
  • Following a strict diet
  • Had bariatric surgery or using medications for weight loss
  • Recent or planned surgical procedures
  • High intake of fish/seafood

结局指标

主要结局

Serum concentration of LDL-cholesterol

时间窗: 8 weeks

LDL-cholesterol will be measured in fasting serum samples

次要结局

  • Serum concentrations of amino acids metabolites(8 weeks)
  • Serum concentration of one-carbon pathway metabolites(8 weeks)
  • Fatty acid composition in leukocytes(8 weeks)
  • Serum concentration of glucose(8 weeks)
  • Serum concentration of insulin(8 weeks)
  • Serum concentration of HDL-cholesterol(8 weeks)
  • Serum concentration of total cholesterol(8 weeks)
  • Serum concentrations of apolipoproteins(8 weeks)
  • Serum concentration of HDL-cholesterol(8 weeks)
  • Serum concentration of total cholesterol(8 weeks)
  • Serum concentrations of apolipoproteins(8 weeks)
  • Serum concentrations of amino acids metabolites(8 weeks)
  • Serum concentration of one-carbon pathway metabolites(8 weeks)
  • Fatty acid composition in leukocytes(8 weeks)
  • Serum concentration of glucose(8 weeks)
  • Serum concentration of insulin(8 weeks)
  • Body composition(8 weeks)

研究者

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

Oddrun Anita Gudbrandsen

Professor

University of Bergen

研究点 (1)

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