Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products

NCT ID: NCT02259205

Last Updated: 2015-04-08

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-10-31

Brief Summary

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This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted from olive mill waste in platelet aggregation and other inflammatory and oxidative stress markers. The study will include three groups: the intervention group will receive the enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt consumption).

Detailed Description

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Cardiovascular diseases are the leading cause of mortality worldwide. Data from the investigators research group indicate that platelet activating factor (PAF) is one of the most important inflammatory factors and the main mediator of thrombosis during the formation of atherosclerotic plaque. Thus, dietary interventions aimed at inhibition of PAF is of particular importance in public health level. The aim of the study is to examine the efficacy of administering in humans bioactive lipids extracted from olive mill waste (with proven in vitro anti-thrombotic activity and in vivo anti-atherosclerotic properties in rabbits fed an atherogenic diet) to inhibit the activity of PAF and other inflammatory mediators.

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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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

Enriched Yogurt

Intervention Type OTHER

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

Group Type PLACEBO_COMPARATOR

Plain Yogurt

Intervention Type OTHER

150 g plain yogurt will be provided daily for 8 weeks

Control

No yogurt consumption

Group Type NO_INTERVENTION

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

Intervention Type OTHER

Plain Yogurt

150 g plain yogurt will be provided daily for 8 weeks

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Any anti-inflammatory medication
* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

Competitiveness and Entrepreneurship (OPCE II), NRSF 2007-13

UNKNOWN

Sponsor Role collaborator

Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Smaragdi Antonopoulou

Professor in Biochemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Smaragdi Antonopoulou, PhD

Role: CONTACT

+302109549100 ext. 230

Tzortzis Nomikos, PhD

Role: CONTACT

+302109549100 ext. 305

Facility Contacts

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George Milias, PhD

Role: primary

+302109549100 ext. 181

Costas Anastasiou, PhD

Role: backup

+302109549100 ext. 181

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.

Reference Type DERIVED
PMID: 38682205 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34071485 (View on PubMed)

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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