Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05417191
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2022-06-09
Brief Title:
Effect of Differently Fed Farmed Gilthead Sea Bream Consumption
Sponsor:
Harokopio University
Organization:
Harokopio University
Study Overview
Official Title:
Effect of Fish Consumption Enriched With Biologically Active Lipids From Olive Pomace on Cardiovascular Risk Factors in Apparently Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial was a double-blind randomized dietary intervention study with a 11 allocation ratio conducted in accordance with the Declaration of Helsinki This study compared two treatments ie 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 240 and 310 kgm2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None