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

Study Overview
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Enriched Yogurt
* Other: Plain Yogurt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enriched Yogurt<br>150 g yogurt enriched with approximately 0.5 g bioactive lipids extract from olive oil mill provided daily for 8 weeks | Other: Enriched Yogurt<br>* 150 g yogurt enriched with bioactive lipids extract from olive oil mill will be provided daily for 8 weeks<br>|
| Placebo Comparator: Plain Yogurt<br>150 g not enriched yogurt provided daily for 8 weeks | Other: Plain Yogurt<br>* 150 g plain yogurt will be provided daily for 8 weeks<br>|
| No Intervention: Control<br>No yogurt consumption | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Platelet aggregation | The ability of platelets to aggregate will be measured in platelet rich plasma (PRP) of volunteers using PAF, thrombin and ADP as aggregating factor. | 0 (baseline), end of 4th week and 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Blood lipid profile | Blood levels of cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerols will be measured. | 0 (baseline), end of 4th week and 8th week | 
| Changes in Glucose and Insulin | Blood levels of glucose and insulin | 0 (baseline), end of 4th week and 8th week | 
| Changes in Gastro-intestinal symptoms | Gastro-intestinal symptoms and possible side effects from yogurt consumption will be assessed through validated questionnaires. | 0 (baseline), end of 4th week and 8th week | 
| Change in Dietary intake | Dietary intake will be assessed through two dietary recalls and a food frequency questionnaire at each time point. | 0 (baseline), end of 8th week | 
| Changes in Oxidative stress | Ex vivo serum oxidation as a marker for lipid oxidation and protein carbonyls as a marker for protein oxidation will be measured. | 0 (baseline), end of 4th week and 8th week | 
| Changes in Gut microbiota populations | the populations of lactobacilli, bifidobacteria and Clostridium histolyticum group will be estimated by real-time PCR using genus specific primers. Furthermore, the metabolic products of the gut microorganisms will be evaluated by measuring the short chain fatty acids profile in fecal samples. | 0 (baseline), end of 8th week | 
| Changes in Inflammation-related markers | C-reactive protein (CRP), IL-6, TNFa, IL-10 levels in fasting blood samples. | 0 (baseline), end of 4th week and 8th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet activating factor, inflammatory markers, yogurt, olive oil, platelet aggregation, oxidative stress, endothelial damage, bioactive lipids