Effect of Differently Fed Farmed Gilthead Sea Bream Consumption

NCT05417191 | Completed

• 1 other identifier: 25/07/2012
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Health

Keywords

fish; sea bream; dietary intervention; olive oil; platelet aggregation; thrombosis; inflammation; cardioprotection

Outcome Measures

Primary Outcomes (5)

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

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

  0 (baseline) and 8 weeks

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

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

  0 (baseline) and 8 weeks

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

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

  0 (baseline) and 8 weeks

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

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

  0 (baseline) and 8 weeks

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

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

  0 (baseline) and 8 weeks

Study Arms (2)

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.

Behavioral: Conventional fish

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.

Behavioral: Enriched fish

Interventions

Conventional fish BEHAVIORAL

Participants initially randomized to this intervention arm will be provided with conventional sea bream fillets and will be asked to consume them twice weekly for 8 weeks. Conventional sea bream fillets will be produced by a fish farming company using standard procedures. Participants will also be instructed to keep the reception of prescribed medications and dietary supplements stable and not to change their lifestyle habits (e.g. other dietary habits besides fish consumption, physical activity habits or sleep habits) during the intervention. After a 6-week wash-out period (no fish consumption), participants will cross over to the other intervention arm.

Conventional fish

Enriched fish BEHAVIORAL

Participants initially randomized to this intervention arm will be provided with conventional sea bream fillets and will be asked to consume them twice weekly for 8 weeks. Conventional sea bream fillets will be produced by a fish farming company using a diet enriched with olive pomace. Participants will also be instructed to keep the reception of prescribed medications and dietary supplements stable and not to change their lifestyle habits (e.g. other dietary habits besides fish consumption, physical activity habits or sleep habits) during the intervention. After a 6-week wash-out period (no fish consumption), participants will cross over to the other intervention arm.

Enriched fish

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Harokopio University: lead
• Nireus Aquaculture: collaborator
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

Kallithea, Attica, 17671, Greece

Location

Related Publications (1)

• Ntzouvani A, Antonopoulou S, Fragopoulou E, Kontogianni MD, Nomikos T, Mikellidi A, Xanthopoulou Mu, Kalogeropoulos N, Panagiotakos D. Effect of Differently Fed Farmed Gilthead Sea Bream Consumption on Platelet Aggregation and Circulating Haemostatic Markers among Apparently Healthy Adults: A Double-Blind Randomized Crossover Trial. Nutrients. 2021 Jan 20;13(2):286. doi: 10.3390/nu13020286.

  PMID: 33498445 BACKGROUND

MeSH Terms

Conditions

Thrombosis; Inflammation

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Smaragdi Antonopoulou, PhD

  Department of Nutrition and Dietetics, Harokopio University

  PRINCIPAL INVESTIGATOR

• Elizabeth Fragopoulou, PhD

  Department of Nutrition and Dietetics, Harokopio University

  STUDY CHAIR

• Tzortzis Nomikos, PhD

  Department of Nutrition and Dietetics, Harokopio University

  STUDY CHAIR

• Meropi D Kontogianni, PhD

  Department of Nutrition and Dietetics, Harokopio University

  STUDY CHAIR

• Michael Georgoulis, PhD

  Department of Nutrition and Dietetics, Harokopio University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Biochemistry

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: December 1, 2012
• Primary Completion: November 30, 2013
• Study Completion: February 28, 2014
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)