Effect of Differently Fed Farmed Gilthead Sea Bream Consumption

Not Applicable

Completed

• Conditions: Cardiometabolic Health
• Interventions: Behavioral: Enriched fish; Behavioral: Conventional fish

• Registration Number: NCT05417191
• Lead Sponsor: Harokopio University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-01
• Primary Completion: 2013-11-30
• Study Completion: 2014-02-28
• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enriched fish	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.
Conventional fish	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline of adenosine diphosphate-induced platelet aggregation at 8 weeks	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	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	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	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	0 (baseline) and 8 weeks	Efficiency concentration fifty of thrombin-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry

Trial Locations

Locations (1)

Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University; 🇬🇷 Kallithéa, Attica, Greece