Effect of Fish Consumption Enriched With Biologically Active Lipids From Olive Pomace, on Cardiovascular Risk Factors in Apparently Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harokopio University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change from baseline of platelet activating factor-induced platelet aggregation at 8 weeks
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 30-65 years old
- •Body Mass Index between 24-31 kg/m^2
- •Habitual fish consumption: <150 g of cooked fish per week
Exclusion Criteria
- •Pregnancy
- •Current or recent weight loss effort
- •Use of dietary supplements
- •Being under treatment for any medical disorder
Arms & Interventions
Conventional fish
This arm will consume 2 portions of gilthead seabream fed with conventional diet. Each portion weighed on average 380 g (raw, quantity of edible fillet approximately 170 g). Participants were instructed to consume fish twice weekly, one portion at a time.
Intervention: Conventional fish (Behavioral)
Enriched fish
This arm will consume 2 portions of gilthead seabream fed with olive pomace enriched diet. Each portion weighed on average 380 g (raw, quantity of edible fillet approximately 170 g). Participants were instructed to consume fish twice weekly, one portion at a time.
Intervention: Enriched fish (Behavioral)
Outcomes
Primary Outcomes
Change from baseline of platelet activating factor-induced platelet aggregation at 8 weeks
Time Frame: 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 adenosine diphosphate-induced platelet aggregation at 8 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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 thrombin-induced platelet aggregation at 8 weeks
Time Frame: 0 (baseline) and 8 weeks
Efficiency concentration fifty of thrombin-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry
Secondary Outcomes
No secondary outcomes reported
Investigators
Smaragdi Antonopoulou
Professor in Biochemistry
Harokopio University
