Oxidative StressNCT02494739
Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
A study testing Yogurt enriched with polyphenols and Yogurt not enriched with polyphenols in people with Oxidative Stress and Inflammation, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation
- What is being tested?
- Yogurt enriched with polyphenols and Yogurt not enriched with polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGreece
- Study dates
- May 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- Non-smokers
Who cannot join
- Current use of dietary supplements or drugs
- Metabolic disease
- Lactose intolerance
- Pregnant, pregnancy intention or breast feeding
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physical Education & Sport Science of the University of Thessaly
Trikala, Karyes, 42100
About this study
Official title: 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.
Read the 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.
- Conditions
- Oxidative Stress, Inflammation
- Being tested
- Yogurt enriched with polyphenols, Yogurt not enriched with polyphenols
- Keywords
- antioxidant, oxidative stress, inflammation, polyphenols, yogurt
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt enriched with polyphenolsOther
Yogurt enriched with polyphenols extracted from grape seeds
Yogurt not enriched with polyphenolsOther
Yogurt not enriched with polyphenols
| Study group | Role | What they receive |
|---|---|---|
| Yogurt enriched with polyphenols | Experimental | Two yogurts (400g) enriched with polyphenols (10mg/100g yogurt) per day, for two weeks. Receives: Other: Yogurt enriched with polyphenols |
| Yogurt not enriched with polyphenols | Placebo comparator | Two yogurts (400g) not enriched with polyphenols per day, for two weeks. Receives: Other: Yogurt not enriched with polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant effects
Indices of blood antioxidant status
Measured: Two weeks
Anti-inflammatory effects
Indices of inflammation in blood
Measured: Two weeks
Secondary outcomes (8)
Body composition
Body fat percentage
Measured: Two weeks
Blood pressure
Blood pressure at rest
Measured: Two weeks
Hydration
Urine specific gravity
Measured: Two weeks
Resting heart rate
Resting heart rate
Measured: Two weeks
Blood glucose levels
Measured: Two weeks
Triglyceride levels
Measured: Two weeks
Total cholesterol levels
Measured: Two weeks
High Density Lipoprotein cholesterol levels
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Athanasios Z Jamurtas, PhD, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494739
- Sponsor's protocol ID
- UniYog-2015x
- Status last verified
- Jan 2016
- First submitted
- 25 Jun 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 24583382Lamothe 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.
PubMed 25154916
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
- ClinicalTrials.gov ID
- NCT02494739
- Acronym / sponsor ID
- UniYog-2015x
- Conditions
- Oxidative Stress, Inflammation
- Keywords
- antioxidant, oxidative stress, inflammation, polyphenols, yogurt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yogurt enriched with polyphenols | Experimental | Other: Yogurt enriched with polyphenolsTwo yogurts (400g) enriched with polyphenols (10mg/100g yogurt) per day, for two weeks. |
| Yogurt not enriched with polyphenols | Placebo comparator | Other: Yogurt not enriched with polyphenolsTwo yogurts (400g) not enriched with polyphenols per day, for two weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals
- Non-smokers
Key exclusion criteria (4 listed)
- Current use of dietary supplements or drugs
- Metabolic disease
- Lactose intolerance
- Pregnant, pregnancy intention or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt enriched with polyphenolsYogurt enriched with polyphenols extracted from grape seeds | Other | Yogurt enriched with polyphenols |
| Yogurt not enriched with polyphenolsYogurt not enriched with polyphenols | Other | Yogurt not enriched with polyphenols |
Primary outcome
Antioxidant effects
Time frame: Two weeks
Indices of blood antioxidant status
Anti-inflammatory effects
Time frame: Two weeks
Indices of inflammation in blood
8 secondary outcomes
Body composition
Time frame: Two weeks
Blood pressure
Time frame: Two weeks
Hydration
Time frame: Two weeks
Resting heart rate
Time frame: Two weeks
Blood glucose levels
Time frame: Two weeks
Triglyceride levels
Time frame: Two weeks
Total cholesterol levels
Time frame: Two weeks
High Density Lipoprotein cholesterol levels
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Background: PubMed 24583382Najgebauer-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.
- Background: PubMed 25154916Lamothe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Z Jamurtas, PhD study director
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt enriched with polyphenols and Yogurt not enriched with polyphenols in people with Oxidative Stress and Inflammation, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant effects (time frame: Two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494739, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.