Effect of Differently Fed Farmed Gilthead Sea Bream Consumption

Cardiometabolic Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05417191
• Other study ID #: 25/07/2012
• Status: Completed
• Phase: N/A
• Start date: December 1, 2012
• Est. completion date: February 28, 2014

Study information

• Verified date: June 2022
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 28, 2014
• Est. primary completion date: November 30, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Health

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University	Kallithéa	Attica

Sponsors (3)

Lead Sponsor	Collaborator
Harokopio University	National and Kapodistrian University of Athens, Nireus Aquaculture

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Ntzouvani A, Antonopoulou S, Fragopoulou E, Kontogianni MD, Nomikos T, Mikellidi A, Xanthopoulou ?, 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). pii: 286. doi: 10.3390/nu13020286. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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