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临床试验/NCT05219890
NCT05219890撤回不适用

Longitudinal Analysis of the Transcriptome From Mononuclear Blood Cells and of the Inflammatory Status of Obese Patients, Supplemented With High Doses of Omega-3 Fatty Acids (EPA and DHA)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran0 个研究点开始时间: 2017年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Changes in serum triglycerides levels

研究概览

简要总结

The main objective is to determine the effect that supplementation with 4.8 g/day of w-3 FA [3.2g eicosapentaenoic acid (EPA) and 1.6 g docosahexaenoic acid (DHA)] have on the inflammatory state of obese patients (BMI ≥ 35.0 kg/m2), at the metabolic, cellular and molecular levels.

详细描述

Methodology Study design. This is a prospective, experimental, comparative, non-blinded (open) study.

Adult obese (BMI ≥ 35.0 kg/m2) patients, age 25 to 45 y, of any gender will be recruited from the outpatient Clinic of Obesity at the INCMNSZ. The patients may have (or not) insulin resistance, but must not have any of the following: type 2 diabetes (controlled or not), hypertension, liver or kidney failure, metabolic syndrome, taking antinflammatory drugs or dietary supplements, and in the case of women, pregnant or lactating.

The control group will consist of 40 healthy adult non-obese volunteers (BMI 18.5 to 23.0 kg/m2), age 25 to 45 y, of any gender who accept to participate in the study. This group will only be studied at the beginning (time 0) and they will not consume the fish oil supplement, since its use will be to obtain reference values for all variables described.

Fish oil supplement will be the source of omega-3 fatty acids (w-3 FA) and this will be a donation from the Inflammation Research Foundation (IRF, Boston MA), in the form of sealed unmarked bottles with 120 capsules/bottle.

Each 1 gram capsule contains 0.6 g of w-3 FA (0.4 g of EPA and 0.2 g of DHA). In order to provide 4.8 g of w-3 FA each obese patient must consume 8 capsules/day, distributed as follows: 2 capsules at breakfast, 4 capsules with the main meal and 2 capsules at dinner.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Control group:
  • healthy adult non-obese volunteers (BMI 18.5 to 23.0 kg/m2)
  • Obese group:
  • metabolically healthy adult obese (BMI ≥ 35.0 kg/m2) patients,

排除标准

  • type 2 diabetes
  • hypertension
  • liver or kidney failure
  • metabolic syndrome
  • taking antinflammatory drugs or dietary supplements
  • in the case of women, pregnant or lactating

结局指标

主要结局

Changes in serum triglycerides levels

时间窗: Within the time of intervention, i. e., 3 months

A reduction in serum triglycerides of at least 5% of initial concentration

次要结局

  • Changes in serum levels of inflammatory proteins, including cytokines(Within the time of intervention, i.e., 3 months)

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Sponsor

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