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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02494739
Other study ID # UniYog-2015x
Secondary ID
Status Completed
Phase N/A
First received June 25, 2015
Last updated January 31, 2016
Start date May 2015
Est. completion date June 2015

Study information

Verified date January 2016
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Yogurt enriched with polyphenols
Yogurt enriched with polyphenols extracted from grape seeds
Yogurt not enriched with polyphenols
Yogurt not enriched with polyphenols

Locations

Country Name City State
Greece Department of Physical Education & Sport Science of the University of Thessaly Trikala Karyes

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Antioxidant effects Indices of blood antioxidant status Two weeks No
Primary Anti-inflammatory effects Indices of inflammation in blood Two weeks No
Secondary Body composition Body fat percentage Two weeks No
Secondary Blood pressure Blood pressure at rest Two weeks No
Secondary Hydration Urine specific gravity Two weeks No
Secondary Resting heart rate Resting heart rate Two weeks No
Secondary Blood glucose levels Two weeks No
Secondary Triglyceride levels Two weeks No
Secondary Total cholesterol levels Two weeks No
Secondary High Density Lipoprotein cholesterol levels Two weeks No
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