- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494739
Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
January 31, 2016 updated by: Athanasios Z. Jamurtas, University of Thessaly
Investigation of the Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
The purpose of this study is to investigate the possible antioxidant and anti-inflammatory effects of yogurt enriched with polyphenols after 2-week consumption by healthy individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eighteen healthy adult volunteers of both sexes consumed yogurt (400g per day) enriched with polyphenols (10mg/100g yogurt) or yogurt (400g per day) not enriched with polyphenols for two weeks in a double-blind, crossover, randomized manner.There was a washout period of at least 10 days.
Physiological data and blood samples were collected before and after consumption of each yogurt.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karyes
-
Trikala, Karyes, Greece, 42100
- Department of Physical Education & Sport Science of the University of Thessaly
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy individuals
- Non-smokers
Exclusion Criteria:
- Current use of dietary supplements or drugs
- Metabolic disease
- Lactose intolerance
- Pregnant, pregnancy intention or breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yogurt enriched with polyphenols
Two yogurts (400g) enriched with polyphenols (10mg/100g yogurt) per day, for two weeks.
|
Yogurt enriched with polyphenols extracted from grape seeds
|
Placebo Comparator: Yogurt not enriched with polyphenols
Two yogurts (400g) not enriched with polyphenols per day, for two weeks.
|
Yogurt not enriched with polyphenols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antioxidant effects
Time Frame: Two weeks
|
Indices of blood antioxidant status
|
Two weeks
|
Anti-inflammatory effects
Time Frame: Two weeks
|
Indices of inflammation in blood
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: Two weeks
|
Body fat percentage
|
Two weeks
|
Blood pressure
Time Frame: Two weeks
|
Blood pressure at rest
|
Two weeks
|
Hydration
Time Frame: Two weeks
|
Urine specific gravity
|
Two weeks
|
Resting heart rate
Time Frame: Two weeks
|
Resting heart rate
|
Two weeks
|
Blood glucose levels
Time Frame: Two weeks
|
Two weeks
|
|
Triglyceride levels
Time Frame: Two weeks
|
Two weeks
|
|
Total cholesterol levels
Time Frame: Two weeks
|
Two weeks
|
|
High Density Lipoprotein cholesterol levels
Time Frame: Two weeks
|
Two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Najgebauer-Lejko D, Grega T, Tabaszewska M. Yoghurts with addition of selected vegetables: acidity, antioxidant properties and sensory quality. Acta Sci Pol Technol Aliment. 2014 Jan-Mar;13(1):35-42. doi: 10.17306/j.afs.2014.1.3.
- Lamothe S, Azimy N, Bazinet L, Couillard C, Britten M. Interaction of green tea polyphenols with dairy matrices in a simulated gastrointestinal environment. Food Funct. 2014 Oct;5(10):2621-31. doi: 10.1039/c4fo00203b. Epub 2014 Aug 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
June 25, 2015
First Submitted That Met QC Criteria
July 7, 2015
First Posted (Estimate)
July 10, 2015
Study Record Updates
Last Update Posted (Estimate)
February 2, 2016
Last Update Submitted That Met QC Criteria
January 31, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniYog-2015x
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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