Clinical trial NCT05417191: Effect of Differently Fed Farmed Gilthead Sea Bream Consumption
Official title: Effect of Fish Consumption Enriched With Biologically Active Lipids From Olive Pomace, on Cardiovascular Risk Factors in Apparently Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Health
Keywords: fish
sea bream
dietary intervention
olive oil
platelet aggregation
thrombosis
inflammation
cardioprotection
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: Nireus Aquaculture
name: National and Kapodistrian University of Athens
First posted: 2022-06-14
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of adenosine diphosphate-induced platelet aggregation at 8 weeks
timeFrame: 0 (baseline) and 8 weeks
measure: Change from baseline of platelet activating factor-induced platelet aggregation at 8 weeks
timeFrame: 0 (baseline) and 8 weeks
measure: Change from baseline of thrombin-induced platelet aggregation at 8 weeks
timeFrame: 0 (baseline) and 8 weeks
measure: Change from baseline in of plasminogen activator inhibitor-1 activity at 8 weeks
timeFrame: 0 (baseline) and 8 weeks
measure: Change from baseline in soluble P-selectin levels at 8 weeks
timeFrame: 0 (baseline) and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kallithéa
country: Greece
facility: Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University
state: Attica
Study officials:
affiliation: Department of Nutrition and Dietetics, Harokopio University
name: Smaragdi Antonopoulou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition and Dietetics, Harokopio University
name: Elizabeth Fragopoulou, PhD
role: STUDY_CHAIR
affiliation: Department of Nutrition and Dietetics, Harokopio University
name: Tzortzis Nomikos, PhD
role: STUDY_CHAIR
affiliation: Department of Nutrition and Dietetics, Harokopio University
name: Meropi D Kontogianni, PhD
role: STUDY_CHAIR
affiliation: Department of Nutrition and Dietetics, Harokopio University
name: Michael Georgoulis, PhD
role: STUDY_CHAIR
References:
citation: 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.