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Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols

Primary Purpose

Oxidative Stress, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Yogurt enriched with polyphenols
Yogurt not enriched with polyphenols
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oxidative Stress focused on measuring antioxidant, oxidative stress, inflammation, polyphenols, yogurt

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Physical Education & Sport Science of the University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yogurt enriched with polyphenols

Yogurt not enriched with polyphenols

Arm Description

Two yogurts (400g) enriched with polyphenols (10mg/100g yogurt) per day, for two weeks.

Two yogurts (400g) not enriched with polyphenols per day, for two weeks.

Outcomes

Primary Outcome Measures

Antioxidant effects
Indices of blood antioxidant status
Anti-inflammatory effects
Indices of inflammation in blood

Secondary Outcome Measures

Body composition
Body fat percentage
Blood pressure
Blood pressure at rest
Hydration
Urine specific gravity
Resting heart rate
Resting heart rate
Blood glucose levels
Triglyceride levels
Total cholesterol levels
High Density Lipoprotein cholesterol levels

Full Information

First Posted
June 25, 2015
Last Updated
January 31, 2016
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT02494739
Brief Title
Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
Official Title
Investigation of the Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation
Keywords
antioxidant, oxidative stress, inflammation, polyphenols, yogurt

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yogurt enriched with polyphenols
Arm Type
Experimental
Arm Description
Two yogurts (400g) enriched with polyphenols (10mg/100g yogurt) per day, for two weeks.
Arm Title
Yogurt not enriched with polyphenols
Arm Type
Placebo Comparator
Arm Description
Two yogurts (400g) not enriched with polyphenols per day, for two weeks.
Intervention Type
Other
Intervention Name(s)
Yogurt enriched with polyphenols
Intervention Description
Yogurt enriched with polyphenols extracted from grape seeds
Intervention Type
Other
Intervention Name(s)
Yogurt not enriched with polyphenols
Intervention Description
Yogurt not enriched with polyphenols
Primary Outcome Measure Information:
Title
Antioxidant effects
Description
Indices of blood antioxidant status
Time Frame
Two weeks
Title
Anti-inflammatory effects
Description
Indices of inflammation in blood
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Body fat percentage
Time Frame
Two weeks
Title
Blood pressure
Description
Blood pressure at rest
Time Frame
Two weeks
Title
Hydration
Description
Urine specific gravity
Time Frame
Two weeks
Title
Resting heart rate
Description
Resting heart rate
Time Frame
Two weeks
Title
Blood glucose levels
Time Frame
Two weeks
Title
Triglyceride levels
Time Frame
Two weeks
Title
Total cholesterol levels
Time Frame
Two weeks
Title
High Density Lipoprotein cholesterol levels
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanasios Z Jamurtas, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical Education & Sport Science of the University of Thessaly
City
Trikala
State/Province
Karyes
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24583382
Citation
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.
Results Reference
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PubMed Identifier
25154916
Citation
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.
Results Reference
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Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols

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