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

Harokopio University

Status: Unknown

Conditions: Cardiovascular Diseases

Treatments: Other: Plain Yogurt; Other: Enriched Yogurt

Study type: Interventional

Funder types: Other

Identifiers

NCT02259205

HUA (Other Identifier)

11SYN-2-652

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups, including a placebo group

Enriched Yogurt

Experimental group

Description:

150 g yogurt enriched with approximately 0.5 g bioactive lipids extract from olive oil mill provided daily for 8 weeks

Treatment:

Other: Enriched Yogurt

Plain Yogurt

Placebo Comparator group

Description:

150 g not enriched yogurt provided daily for 8 weeks

Treatment:

Other: Plain Yogurt

Control

No Intervention group

Description:

No yogurt consumption