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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02259205
• Other study ID #: 11SYN-2-652
• Secondary ID: HUA
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2014
• Last updated: April 7, 2015
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2015
• Source: Harokopio University
• Contact: Smaragdi Antonopoulou, PhD
• Phone: +302109549100
• Email: antonop[@]hua.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• 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

Locations

Country	Name	City	State
Greece	Harokopio University, Department of Nutrition and Dietetics	Athens	Attiki

Sponsors (3)

Lead Sponsor	Collaborator
Harokopio University	Competitiveness and Entrepreneurship (OPCE II), NRSF 2007-13, National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Changes in Glucose and Insulin	Blood levels of glucose and insulin	0 (baseline), end of 4th week and 8th week	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No