Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products
NCT ID: NCT02259205
Last Updated: 2015-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2014-09-30
2015-10-31
Brief Summary
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Detailed Description
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Bioactive lipids are isolated by standardized methodology of oil manufacture byproducts. Preliminary studies have been done in animals to establish the safety of administration of these compounds and to clarify the effective dosages of administration for inhibiting formation of atherosclerotic plaques. The effectiveness of these compounds in humans will be examined in a randomized, double-blind clinical trial in subjects aged 40-60 years, lasting eight weeks. Supplementation with the bioactive lipids will be in the form of an enriched yogurt provided daily. The study includes three groups: treatment group, where enriched yogurt will be provided, plain yogurt treatment group and no consumption of yogurt group . Parameters that will be assessed are the inhibition of platelet aggregation (with three different stimuli, including PAF), lipid profile, inflammatory markers such as CRP, IL-6, TNFa, and oxidative stress markers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Enriched Yogurt
150 g yogurt enriched with approximately 0.5 g bioactive lipids extract from olive oil mill provided daily for 8 weeks
Enriched Yogurt
150 g yogurt enriched with bioactive lipids extract from olive oil mill will be provided daily for 8 weeks
Plain Yogurt
150 g not enriched yogurt provided daily for 8 weeks
Plain Yogurt
150 g plain yogurt will be provided daily for 8 weeks
Control
No yogurt consumption
No interventions assigned to this group
Interventions
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Enriched Yogurt
150 g yogurt enriched with bioactive lipids extract from olive oil mill will be provided daily for 8 weeks
Plain Yogurt
150 g plain yogurt will be provided daily for 8 weeks
Eligibility Criteria
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Exclusion Criteria
* Hyper-lipidemic medications
* Use of antibiotics within two months from study entry
* Pregnancy or childbirth in the previous year
* Intake of any nutritional supplement
* Any serious dental, respiratory, liver, kidney, gastrointestinal disease
40 Years
60 Years
ALL
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Competitiveness and Entrepreneurship (OPCE II), NRSF 2007-13
UNKNOWN
Harokopio University
OTHER
Responsible Party
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Smaragdi Antonopoulou
Professor in Biochemistry
Principal Investigators
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Smaragdi Antonopoulou, PhD
Role: PRINCIPAL_INVESTIGATOR
Harokopio University, Department of Nutrition and Dietetics
Elizabeth Frafopoulou, PhD
Role: STUDY_CHAIR
Harokopio University, Department of Nutrition and Dietetics
Tzortzis Nomikos, PhD
Role: STUDY_CHAIR
Harokopio University, Department of Nutrition and Dietetics
Locations
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Harokopio University, Department of Nutrition and Dietetics
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Antonopoulou S, Mitsou EK, Kyriacou A, Fragopoulou E, Detopoulou M. Does Yogurt Enriched with Platelet-Activating Factor Inhibitors from Olive Oil By-Products Affect Gut Microbiota and Faecal Metabolites in Healthy Overweight Subjects? (A randomized, parallel, three arm trial.). Front Biosci (Landmark Ed). 2024 Apr 23;29(4):159. doi: 10.31083/j.fbl2904159.
Detopoulou M, Ntzouvani A, Petsini F, Gavriil L, Fragopoulou E, Antonopoulou S. Consumption of Enriched Yogurt with PAF Inhibitors from Olive Pomace Affects the Major Enzymes of PAF Metabolism: A Randomized, Double Blind, Three Arm Trial. Biomolecules. 2021 May 28;11(6):801. doi: 10.3390/biom11060801.
Other Identifiers
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HUA
Identifier Type: OTHER
Identifier Source: secondary_id
11SYN-2-652
Identifier Type: -
Identifier Source: org_study_id
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