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Cardiometabolic HealthNCT05417191

Effect of Differently Fed Farmed Gilthead Sea Bream Consumption

A study testing Conventional fish and Enriched fish in people with Cardiometabolic Health, run by Harokopio University at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cardiometabolic Health
What is being tested?
Conventional fish and Enriched fish
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteGreece
Study dates
1 Dec 2012to 28 Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

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

    Kallithea, Attica, 17671

Other trials in Greece

About this study

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

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.

Being tested
Conventional fish, Enriched fish
Keywords
fish, sea bream, dietary intervention, olive oil, platelet aggregation, thrombosis, inflammation, cardioprotection
Medical subject headings
Thrombosis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional fishBehavioural

    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 fishBehavioural

    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.

Study groups in NCT05417191
Study groupRoleWhat they receive
Conventional fishActive comparatorThis 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.
Receives: Behavioral: Conventional fish
Enriched fishExperimentalThis 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.
Receives: Behavioral: Enriched fish

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 0 (baseline) and 8 weeks

  2. 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

    Measured: 0 (baseline) and 8 weeks

  3. 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

    Measured: 0 (baseline) and 8 weeks

  4. 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

    Measured: 0 (baseline) and 8 weeks

  5. 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

    Measured: 0 (baseline) and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start1 Dec 2012
  3. Primary completion30 Nov 2013
  4. Study completion28 Feb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05417191
Sponsor's protocol ID
25/07/2012
Status last verified
Jun 2022
First submitted
9 Jun 2022
Last updated
14 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data will be shared to investigators for the purpose of individual participant data meta-analysis, provided that the proposed use of the data has been approved by the Study Principal Investigator. Proposals should be directed to antonop@hua.gr. To gain access, data requestors will need to sign a data access agreement.

Publications

  • 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.

    PubMed 33498445

Questions about this trial

What is this clinical trial studying?

A study testing Conventional fish and Enriched fish in people with Cardiometabolic Health, run by Harokopio University at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of adenosine diphosphate-induced platelet aggregation at 8 weeks (time frame: 0 (baseline) and 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05417191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

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