NCT02494739

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

June 25, 2015

Last Update Submit

January 31, 2016

Conditions

Keywords

antioxidantoxidative stressinflammationpolyphenolsyogurt

Outcome Measures

Primary Outcomes (2)

  • Antioxidant effects

    Indices of blood antioxidant status

    Two weeks

  • Anti-inflammatory effects

    Indices of inflammation in blood

    Two weeks

Secondary Outcomes (8)

  • Body composition

    Two weeks

  • Blood pressure

    Two weeks

  • Hydration

    Two weeks

  • Resting heart rate

    Two weeks

  • Blood glucose levels

    Two weeks

  • +3 more secondary outcomes

Study Arms (2)

Yogurt enriched with polyphenols

EXPERIMENTAL

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

Other: Yogurt enriched with polyphenols

Yogurt not enriched with polyphenols

PLACEBO COMPARATOR

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

Other: Yogurt not enriched with polyphenols

Interventions

Yogurt enriched with polyphenols extracted from grape seeds

Yogurt enriched with polyphenols

Yogurt not enriched with polyphenols

Yogurt not enriched with polyphenols

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals
  • Non-smokers

You may not qualify if:

  • Current use of dietary supplements or drugs
  • Metabolic disease
  • Lactose intolerance
  • Pregnant, pregnancy intention or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Trikala, Karyes, 42100, Greece

Location

Related Publications (2)

  • 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.

    PMID: 24583382BACKGROUND
  • 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.

    PMID: 25154916BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Polyphenols

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Athanasios Z Jamurtas, PhD

    University of Thessaly

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 10, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 2, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations