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临床试验/NCT05417191
NCT05417191已完成不适用

Effect of Fish Consumption Enriched With Biologically Active Lipids From Olive Pomace, on Cardiovascular Risk Factors in Apparently Healthy Volunteers

Harokopio University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Change from baseline of adenosine diphosphate-induced platelet aggregation at 8 weeks

研究概览

简要总结

The trial was a double-blind randomized dietary intervention study with a 1:1 allocation ratio, conducted in accordance with the Declaration of Helsinki. This study compared two treatments, i.e., farmed fish fed with olive pomace enriched diet (enriched fish; EF) versus farmed fish fed with fish oil diet (conventional fish; CF), using a crossover design. The study lasted 22 weeks; treatment period one (8 weeks, mid-January-end of March), washout period (6 weeks), and treatment period two (8 weeks, mid-May-end of July). The participants were equally distributed to the two treatments along treatment periods. Eligible subjects were all adults aged between 30 and 65 years old with a body mass index (BMI) between 24.0 and 31.0 kg/m2 who met the eligibility criteria for habitual fish consumption (<150 g of cooked fish per week). Exclusion criteria were pregnancy, current or recent weight loss effort, use of dietary supplements and being under treatment for any medical disorder. Subjects were allowed to use medical treatment for thyroid gland disorders, iron or folic acid supplements, contraceptives or hormone replacement therapy (HRT) for women, provided they would continue receiving their medication throughout the study. The aim of the study was to evaluate the effects of consumption of fillets from differently fed farmed gilthead sea bream on markers of cardiometabolic health such as platelet aggregation, circulating haemostatic markers, markers of inflammation and oxidative stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 30-65 years old
  • Body Mass Index between 24-31 kg/m^2
  • Habitual fish consumption: <150 g of cooked fish per week

排除标准

  • Pregnancy
  • Current or recent weight loss effort
  • Use of dietary supplements
  • Being under treatment for any medical disorder

结局指标

主要结局

Change from baseline of adenosine diphosphate-induced platelet aggregation at 8 weeks

时间窗: 0 (baseline) and 8 weeks

Efficiency concentration fifty of adenosine diphosphate-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry

Change from baseline in of plasminogen activator inhibitor-1 activity at 8 weeks

时间窗: 0 (baseline) and 8 weeks

Plasminogen activator inhibitor-1 activity (mAU/mL) will be measured in blood samples using commercially available ELISA kits

Change from baseline in soluble P-selectin levels at 8 weeks

时间窗: 0 (baseline) and 8 weeks

Soluble P-selectin levels (ng/mL) will be measured in blood samples using commercially available ELISA kits

Change from baseline of platelet activating factor-induced platelet aggregation at 8 weeks

时间窗: 0 (baseline) and 8 weeks

Efficiency concentration fifty of platelet activating factor-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry

Change from baseline of thrombin-induced platelet aggregation at 8 weeks

时间窗: 0 (baseline) and 8 weeks

Efficiency concentration fifty of thrombin-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry

次要结局

未报告次要终点

研究者

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

Smaragdi Antonopoulou

Professor in Biochemistry

Harokopio University

研究点 (2)

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