NCT02259205

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

September 24, 2014

Last Update Submit

April 7, 2015

Conditions

Cardiovascular Diseases

Keywords

platelet activating factorinflammatory markersyogurtolive oilplatelet aggregationoxidative stressendothelial damagebioactive lipids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Changes in Blood lipid profile

    0 (baseline), end of 4th week and 8th week

  • Changes in Glucose and Insulin

    0 (baseline), end of 4th week and 8th week

  • Changes in Gastro-intestinal symptoms

    0 (baseline), end of 4th week and 8th week

  • Change in Dietary intake

    0 (baseline), end of 8th week

  • Changes in Oxidative stress

    0 (baseline), end of 4th week and 8th week

  • +2 more secondary outcomes

Study Arms (3)

Enriched Yogurt

EXPERIMENTAL

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

Other: Enriched Yogurt

Plain Yogurt

PLACEBO COMPARATOR

150 g not enriched yogurt provided daily for 8 weeks

Other: Plain Yogurt

Control

NO INTERVENTION

No yogurt consumption

Interventions

Enriched YogurtOTHER

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

Enriched Yogurt
Plain YogurtOTHER

150 g plain yogurt will be provided daily for 8 weeks

Plain Yogurt

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harokopio University, Department of Nutrition and Dietetics

Athens, Attica, 17671, Greece

RECRUITING

Related Publications (2)

  • Antonopoulou S, Mitsou EK, Kyriacou A, Fragopoulou E, Detopoulou M. Does Yogurt Enriched with Platelet-Activating Factor Inhibitors from Olive Oil By-Products Affect Gut Microbiota and Faecal Metabolites in Healthy Overweight Subjects? (A randomized, parallel, three arm trial.). Front Biosci (Landmark Ed). 2024 Apr 23;29(4):159. doi: 10.31083/j.fbl2904159.

    PMID: 38682205DERIVED

  • 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.

    PMID: 34071485DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Smaragdi Antonopoulou, PhD

    Harokopio University, Department of Nutrition and Dietetics

    PRINCIPAL INVESTIGATOR

  • Elizabeth Frafopoulou, PhD

    Harokopio University, Department of Nutrition and Dietetics

    STUDY CHAIR

  • Tzortzis Nomikos, PhD

    Harokopio University, Department of Nutrition and Dietetics

    STUDY CHAIR

Central Study Contacts

Smaragdi Antonopoulou, PhD

CONTACT

+302109549100antonop@hua.gr

Tzortzis Nomikos, PhD

CONTACT

+302109549100tnomikos@hua.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Biochemistry

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 8, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

GR(1)