Oxidative StressEarly Phase 1NCT02293486
Study of Pomegranate Juice in the Modulation of Oxidative Stress Markers in Endurance-based Athletes
A Early Phase 1 study testing Pomegranate juice in people with Oxidative Stress, run by Universidad Miguel Hernandez de Elche.
Trial summary
The purpose of this study is to evaluate modifications of plasma protein carbonyls and malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice consumption. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Pomegranate juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Feb 2013
- Phase
- Early Phase 1
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Perform specific endurance training sessions
- More than 1 hour per session and more than 3 sessions per week
- Have participated recently in a half marathon or similar event
Who cannot join
- Intake of antioxidant or anti-inflammatory supplementation
- Present a chronic disorder
- Non-smoker
- No-alcoholic beverage consumption
About this study
The purpose of this study is to evaluate modifications of plasma protein carbonyls and malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice consumption.
- Conditions
- Oxidative Stress
- Being tested
- Pomegranate juice
- Keywords
- Antioxidants, Protein Carbonylation, Malondialdehyde, Punicaceae, Athletic Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate juiceDietary supplement
Also called Zumo de Granada Vitalgrana
Intake of 200 ml of pomegranate juice or pomegranate juice dilution during 21 days after exercise.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Arm that followed all the protocols with the exception of the pomegranate juice intake. |
| Pomegranate Juice | Experimental | Arm that followed all the protocols and the pomegranate juice intake. Receives: Dietary Supplement: Pomegranate juice |
| Pomegranate Juice Dilution | Experimental | Arm that followed all the protocols and the pomegranate juice dilution (1:1) intake. Receives: Dietary Supplement: Pomegranate juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein carbonyls levels changes in plasma
Protein carbonyl derivatives were determined using an adaptation of the colorimetric method published in Levine et al. (1994) based in the formation of a stable 2,4-dinitrophenyl (DNP) hydrazone product after the addition of 2,4-dinitrophenylhydrazine (DNPH) to tha plasma. Protein carbonyls were calculated as nmoles·mg-1 protein
Measured: day 0 and 22
Malondialdehyde levels changes in plasma
Malondialdehyde was determined by high pressure liquid chromatography (HPLC) with fluorescence detection according to the method described by Laporta et al. (2007). Malondialdehyde levels were calculated as nmoles·g-1 protein
Measured: day 0 and 22
Secondary outcomes (3)
Blood biochemical parameters changes in plasma
Blood biochemical parameters is a composite outcome measure consisting in circulating plasma glucose (mg·dL-1), HDL-cholesterol (mg·dL-1), triglycerides (mg·dL-1), ferritin (ng·mL-1), lactate (mg·dL-1), sodium (mEq·L-1), potassium (mEq·L-1), creatine kinase (U·L-1), aspartate aminotransferase (U·L-1) and alanine aminotransferase (U·L-1) were analyzed through biochemistry methods.
Measured: day 0 and 22
C-reactive protein levels changes in plasma
Determination by immunoassay of C-reactive protein (ng·mL-1) levels in plasma.
Measured: day 0 and 22
Soluble E-selectin levels changes in plasma
Determination by immunoassay of soluble E-selectin (ng·mL-1) levels in plasma.
Measured: day 0 and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionFeb 2013
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Vitalgrana Pomegranate SL
- Responsible party
- Principal investigator, Néstor Vicente-Salar, Universidad Miguel Hernandez de Elche
- Investigators
- Enrique Roche, PhD, Study director, University Miguel Hernández
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293486
- Sponsor's protocol ID
- GRA 01
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aviram M, Dornfeld L, Rosenblat M, Volkova N, Kaplan M, Coleman R, Hayek T, Presser D, Fuhrman B. Pomegranate juice consumption reduces oxidative stress, atherogenic modifications to LDL, and platelet aggregation: studies in humans and in atherosclerotic apolipoprotein E-deficient mice. Am J Clin Nutr. 2000 May;71(5):1062-76. doi: 10.1093/ajcn/71.5.1062.
PubMed 10799367Trombold JR, Reinfeld AS, Casler JR, Coyle EF. The effect of pomegranate juice supplementation on strength and soreness after eccentric exercise. J Strength Cond Res. 2011 Jul;25(7):1782-8. doi: 10.1519/JSC.0b013e318220d992.
PubMed 21659887
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pomegranate Juice in the Modulation of Oxidative Stress Markers in Endurance-based Athletes
- ClinicalTrials.gov ID
- NCT02293486
- Acronym / sponsor ID
- GRA 01
- Conditions
- Oxidative Stress
- Keywords
- Antioxidants, Protein Carbonylation, Malondialdehyde, Punicaceae, Athletic Performance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Vitalgrana Pomegranate SL
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Nov 2014 (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 evaluate modifications of plasma protein carbonyls and malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Arm that followed all the protocols with the exception of the pomegranate juice intake. |
| Pomegranate Juice | Experimental | Dietary Supplement: Pomegranate juiceArm that followed all the protocols and the pomegranate juice intake. |
| Pomegranate Juice Dilution | Experimental | Dietary Supplement: Pomegranate juiceArm that followed all the protocols and the pomegranate juice dilution (1:1) intake. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Perform specific endurance training sessions
- More than 1 hour per session and more than 3 sessions per week
- Have participated recently in a half marathon or similar event
Key exclusion criteria (4 listed)
- Intake of antioxidant or anti-inflammatory supplementation
- Present a chronic disorder
- Non-smoker
- No-alcoholic beverage consumption
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 |
|---|---|---|
| Pomegranate juiceAlso: Zumo de Granada VitalgranaIntake of 200 ml of pomegranate juice or pomegranate juice dilution during 21 days after exercise. | Dietary supplement | Pomegranate Juice, Pomegranate Juice Dilution |
Primary outcome
Protein carbonyls levels changes in plasma
Time frame: day 0 and 22
Protein carbonyl derivatives were determined using an adaptation of the colorimetric method published in Levine et al. (1994) based in the formation of a stable 2,4-dinitrophenyl (DNP) hydrazone product after the addition of 2,4-dinitrophenylhydrazine (DNPH) to tha plasma. Protein carbonyls were calculated as nmoles·mg-1 protein
Malondialdehyde levels changes in plasma
Time frame: day 0 and 22
Malondialdehyde was determined by high pressure liquid chromatography (HPLC) with fluorescence detection according to the method described by Laporta et al. (2007). Malondialdehyde levels were calculated as nmoles·g-1 protein
3 secondary outcomes
Blood biochemical parameters changes in plasma
Time frame: day 0 and 22
C-reactive protein levels changes in plasma
Time frame: day 0 and 22
Soluble E-selectin levels changes in plasma
Time frame: day 0 and 22
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 18 Nov 2014.
- Results publication: PubMed 10799367Aviram M, Dornfeld L, Rosenblat M, Volkova N, Kaplan M, Coleman R, Hayek T, Presser D, Fuhrman B. Pomegranate juice consumption reduces oxidative stress, atherogenic modifications to LDL, and platelet aggregation: studies in humans and in atherosclerotic apolipoprotein E-deficient mice. Am J Clin Nutr. 2000 May;71(5):1062-76. doi: 10.1093/ajcn/71.5.1062.
- Results publication: PubMed 21659887Trombold JR, Reinfeld AS, Casler JR, Coyle EF. The effect of pomegranate juice supplementation on strength and soreness after eccentric exercise. J Strength Cond Res. 2011 Jul;25(7):1782-8. doi: 10.1519/JSC.0b013e318220d992.
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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.
Enrique Roche, PhD study director
University Miguel Hernández
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pomegranate juice in people with Oxidative Stress, run by Universidad Miguel Hernandez de Elche.
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 3 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Protein carbonyls levels changes in plasma (time frame: day 0 and 22). 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 NCT02293486, 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 18 Nov 2014.