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临床试验/NCT02183922
NCT02183922已完成不适用

Hypocaloric Diet With or Without Microencapsulated Fish Oil or Conjugated Linoleic Acid on Oxidative Stress and Cardiovascular Risk Factors in Women With Metabolic Syndrome Genotyped for Polymorphisms in the Genes PPAR Gamma 2 (Pro12Ala) and Adiponectin (G276T)

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2008年5月1日最近更新:
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
37
试验地点
1
主要终点
Oxidative stress biomarker

研究概览

简要总结

Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body composition, insulin resistance and lipid profile in women with metabolic syndrome and genotype Pro12Pro in the PPAR gamma 2 gene.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •adults women (30-45 years old);
  • •diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;
  • •Pro12Pro genotype in gene PPARγ2.

排除标准

  • •Participants were excluded if they:
  • •Were allergic to strawberries or fish
  • •Were pregnant or lactating
  • •Took fatty acid supplements
  • •Had undergone bariatric surgery or were being treated nutritionally or pharmacologically for reducing BM, or had taken anti-obesity drugs during the previous three months

研究组 & 干预措施

light fruit jam

Placebo Comparator

The placebo group received light fruit jam (15 g/day) during 12 weeks.

干预措施: light fruit jam (Dietary Supplement)

microencapsulated fish oil

Experimental

The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.

干预措施: microencapsulated fish oil (Dietary Supplement)

microencapsulated conjugated linoleic acid

Experimental

The microencapsulated conjugated linoleic acid group received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.

干预措施: microencapsulated conjugated linoleic acid (Dietary Supplement)

结局指标

主要结局

Oxidative stress biomarker

时间窗: Change from baseline at 12 weeks

Plasma malondialdehyde levels

次要结局

  • Blood pressure(Change from baseline at 12 weeks)
  • Insulin resistance(Change from baseline at 12 weeks)
  • Lipid profile(Change from baseline at 12 weeks)
  • Anthropometric measures(Change from baseline at 12 weeks)
  • Body composition measures(Change from baseline at 12 weeks)

研究者

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

Sofia Kimi Uehara

Doctor

Universidade Federal do Rio de Janeiro

研究点 (1)

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