Effect of Fish Consumption Enriched With Biologically Active Lipids From Olive Pomace, on Cardiovascular Risk Factors in Apparently Healthy Volunteers
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
- 是
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
Smaragdi Antonopoulou
Professor in Biochemistry
Harokopio University
