Effect of Differently Fed Farmed Gilthead Sea Bream Consumption

Sponsor
Harokopio University (Other)
Overall Status
Completed
CT.gov ID
NCT05417191
Collaborator
Nireus Aquaculture (Other), National and Kapodistrian University of Athens (Other)
38
1
2
14.9
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Conventional fish
  • Behavioral: Enriched fish
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Fish Consumption Enriched With Biologically Active Lipids From Olive Pomace, on Cardiovascular Risk Factors in Apparently Healthy Volunteers
Actual Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Nov 30, 2013
Actual Study Completion Date :
Feb 28, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Behavioral: Conventional fish
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.

Experimental: 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.

Behavioral: Enriched fish
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University Kallithéa Attica Greece 17671

Sponsors and Collaborators

  • Harokopio University
  • Nireus Aquaculture
  • National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: Smaragdi Antonopoulou, PhD, Department of Nutrition and Dietetics, Harokopio University
  • Study Chair: 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 Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Smaragdi Antonopoulou, Professor in Biochemistry, Harokopio University
ClinicalTrials.gov Identifier:
NCT05417191
Other Study ID Numbers:
  • 25/07/2012
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Smaragdi Antonopoulou, Professor in Biochemistry, Harokopio University

Study Results

No Results Posted as of Jun 14, 2022