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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 April 2015 |
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Main ID: |
NCT02259205 |
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Date of registration:
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24/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products
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Scientific title:
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Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02259205 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Elizabeth Frafopoulou, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harokopio University, Department of Nutrition and Dietetics |
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Name:
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Smaragdi Antonopoulou, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harokopio University, Department of Nutrition and Dietetics |
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Name:
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Smaragdi Antonopoulou, PhD |
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Address:
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Telephone:
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+302109549100 |
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Email:
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antonop@hua.gr |
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Affiliation:
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Name:
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George Milias, PhD |
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Address:
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Telephone:
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+302109549100 |
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Email:
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gmilias@yahoo.com |
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Affiliation:
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Name:
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Tzortzis Nomikos, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harokopio University, Department of Nutrition and Dietetics |
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Key inclusion & exclusion 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
Age minimum:
40 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Intervention(s)
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Other: Enriched Yogurt
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Other: Plain Yogurt
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Primary Outcome(s)
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Changes in Platelet aggregation
[Time Frame: 0 (baseline), end of 4th week and 8th week]
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Secondary Outcome(s)
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Changes in Gastro-intestinal symptoms
[Time Frame: 0 (baseline), end of 4th week and 8th week]
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Changes in Oxidative stress
[Time Frame: 0 (baseline), end of 4th week and 8th week]
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Change in Dietary intake
[Time Frame: 0 (baseline), end of 8th week]
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Changes in Glucose and Insulin
[Time Frame: 0 (baseline), end of 4th week and 8th week]
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Changes in Inflammation-related markers
[Time Frame: 0 (baseline), end of 4th week and 8th week]
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Changes in Blood lipid profile
[Time Frame: 0 (baseline), end of 4th week and 8th week]
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Changes in Gut microbiota populations
[Time Frame: 0 (baseline), end of 8th week]
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Secondary ID(s)
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11SYN-2-652
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HUA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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