Clinical trial NCT02259205: Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products
Official title: Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: platelet activating factor
inflammatory markers
yogurt
olive oil
platelet aggregation
oxidative stress
endothelial damage
bioactive lipids
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: Competitiveness and Entrepreneurship (OPCE II), NRSF 2007-13
First posted: 2014-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* All individuals, aged 40-60 years, without any of the exclusion criteria

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

Primary outcomes:
measure: Changes in Platelet aggregation
timeFrame: 0 (baseline), end of 4th week and 8th week
Secondary outcomes:
measure: Changes in Blood lipid profile
timeFrame: 0 (baseline), end of 4th week and 8th week
measure: Changes in Glucose and Insulin
timeFrame: 0 (baseline), end of 4th week and 8th week
measure: Changes in Gastro-intestinal symptoms
timeFrame: 0 (baseline), end of 4th week and 8th week
measure: Change in Dietary intake
timeFrame: 0 (baseline), end of 8th week
measure: Changes in Oxidative stress
timeFrame: 0 (baseline), end of 4th week and 8th week
measure: Changes in Gut microbiota populations
timeFrame: 0 (baseline), end of 8th week
measure: Changes in Inflammation-related markers
timeFrame: 0 (baseline), end of 4th week and 8th week
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University, Department of Nutrition and Dietetics
state: Attiki
Study officials:
affiliation: Harokopio University, Department of Nutrition and Dietetics
name: Smaragdi Antonopoulou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harokopio University, Department of Nutrition and Dietetics
name: Elizabeth Frafopoulou, PhD
role: STUDY_CHAIR
affiliation: Harokopio University, Department of Nutrition and Dietetics
name: Tzortzis Nomikos, PhD
role: STUDY_CHAIR
References:
citation: 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.