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

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).

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Enriched Yogurt; Other: Plain Yogurt

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 17671
      • Recruiting
      • Harokopio University, Department of Nutrition and Dietetics
      • Contact: George Milias, PhD; Phone Number: 181 +302109549100; Email: gmilias@yahoo.com
      • Contact: Costas Anastasiou, PhD; Phone Number: 181 +302109549100; Email: acostas@hua.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Harokopio University
• Collaborators: National and Kapodistrian University of Athens; Competitiveness and Entrepreneurship (OPCE II), NRSF 2007-13
• Investigators: Principal Investigator: Smaragdi Antonopoulou, PhD, Harokopio University, Department of Nutrition and Dietetics; Study Chair: Elizabeth Frafopoulou, PhD, Harokopio University, Department of Nutrition and Dietetics; Study Chair: Tzortzis Nomikos, PhD, Harokopio University, Department of Nutrition and Dietetics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 8, 2014

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: platelet aggregation; oxidative stress; olive oil; yogurt; inflammatory markers; platelet activating factor; endothelial damage; bioactive lipids
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 11SYN-2-652; HUA (OTHER: Harokopio University)