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Clinical Trials/NCT05417191
NCT05417191CompletedNot Applicable

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

Harokopio University1 site in 1 country38 target enrollmentStarted: December 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Active Comparator

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

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Smaragdi Antonopoulou

Professor in Biochemistry

Harokopio University

Study Sites (1)

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