HealthyPhase 4PROBELTEIINCT02042742
Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers
A Phase 4 study testing punicalagin and hydroxytyrosol mixture in people with Healthy, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2. Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an 8 wk each phase with 4-wk rest period. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- punicalagin and hydroxytyrosol mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Oct 2013
- Phase
- Phase 4
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women from 45 to 75 years old;
- Signed informed consent
Who cannot join
- Individuals with cardiovascular risk factors on drug treatment (dyslipidemia, hypertension, Diabetes Mellitus);
- Individuals with Metabolic Syndrome;
- Individuals with familiar background of premature cardiovascular disease;
- Individuals with BMI ≥ 30 kg/m2;
- Women that still maintain your menstrual cycle;
- Individuals with increased alcohol consumption 30g/day;
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- Individuals that stop smoking in the next 20 weeks (during the study);
- Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics;
- Women that consume oral contraceptive;
- Individuals with mental disease or low cognitive function;
- Individuals with severe diseases (hepatic, kidney, cancer…);
- Individuals with drugs or supplements consumption to weight lost;
- Pregnant women or lactating;
- Individuals with intensive physical activity;
- Individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers Related With Cardiovascular Disease: a Crossover Study in Healthy Middle-aged Volunteers
A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2. Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an 8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical markers), inflammatory markers and nutritional status were evaluated before and after each phase. Previously a pilot study was completed with no placebo (n=30) to determinate the effective dose of Functional Supplement.
- Conditions
- Healthy
- Being tested
- punicalagin and hydroxytyrosol mixture, Control supplement (maltodextrin)
- Keywords
- Cross-over studies, Antioxidants, Hydroxytyrosol, Punicalagin, Treatment outcome, Inflammatory markers, Endothelial function, Humans, Adults, volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
punicalagin and hydroxytyrosol mixtureDietary supplement
Also called Punicalagin and hydroxytyrosol
Antioxidant Supplement (punicalagin and hydroxytyrosol mixture) During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity.
Control supplement (maltodextrin)Dietary supplement
Also called Maltodextrin
During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant supplement | Experimental | Treatment consist of consuming 65g of punicalagin and 3,3g of hydroxytyrosol (plus 331,7g of maltodextrin) three times daily, during 8 weeks. Receives: Dietary Supplement: punicalagin and hydroxytyrosol mixture |
| Control supplement | Placebo comparator | Treatment consist of consuming 400g of maltodextrin three times daily, during 8 weeks. Receives: Dietary Supplement: Control supplement (maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Inflammatory markers after 8 weeks treatment
Inflammatory markers (Fibrinogen, gelsolin, thrombospondin, interleukin 6 and PCR) will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II
Measured: 0, 8, 12 and 20 weeks
Secondary outcomes (8)
Change in Oxidative Stress Parameters
Parameters measured were: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), oxidized LDL, paraoxonase 1, F2-isoprostanes. Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II.
Measured: 0, 8, 12 and 20 weeks
Change in Glucose Metabolism
Parameters measured were: glucose, basal insulin, HbA1c (in diabetic patients), HOMA (homeostasis model assessment ) index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR ( (homeostasis model assessment insulin resistance) = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5).Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II
Measured: 0, 8, 12 and 20 weeks
Change in Lipid profile
Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides. Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II
Measured: 0, 8, 12 and 20 weeks
Change in Endothelial function
Parameters measured were: Brachial artery flow-mediated dilation (FMD), blood pressure, eNOS, vascular endothelial cell adhesion molecule -1 and p-selectin. Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II
Measured: 0, 8, 12 and 20 weeks
Change in Coagulation markers
Parameters measured were: Prothrombin time and activity, INR. Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II
Measured: 0, 8, 12 and 20 weeks
Change in Anthropometric and body composition parameters
Parameters measured were: Weight, Height and waist circumference, muscle mass percentage (MM%), fat mass percentage (FM%), free fat mass percentage(FM%). Will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II
Measured: 0, 8, 12 and 20 weeks
Adverse effects
Parameters measured were: transaminases and creatinine. Will be evaluated during all the study visits
Measured: 0 to 20 weeks
Adherence and Tolerance Parameters
Parameters measured were: adherence and tolerance to the products. Will be evaluated during all study visits.
Measured: 0 to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042742
- Sponsor's protocol ID
- PROBELTEII
- Acronym
- PROBELTEII
- Status last verified
- Jan 2014
- First submitted
- 27 Dec 2013
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers Related With Cardiovascular Disease: a Crossover Study in Healthy Middle-aged Volunteers
- ClinicalTrials.gov ID
- NCT02042742
- Acronym / sponsor ID
- PROBELTEII / PROBELTEII
- Conditions
- Healthy
- Keywords
- Cross-over studies, Antioxidants, Hydroxytyrosol, Punicalagin, Treatment outcome, Inflammatory markers, Endothelial function, Humans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Jan 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.
A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2. Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an 8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical markers), inflammatory markers and nutritional status were evaluated before and after each phase. Previously a pilot study was completed with no placebo (n=30) to determinate the effective dose of Functional Supplement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant supplement | Experimental | Dietary Supplement: punicalagin and hydroxytyrosol mixtureTreatment consist of consuming 65g of punicalagin and 3,3g of hydroxytyrosol (plus 331,7g of maltodextrin) three times daily, during 8 weeks. |
| Control supplement | Placebo comparator | Dietary Supplement: Control supplement (maltodextrin)Treatment consist of consuming 400g of maltodextrin three times daily, during 8 weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women from 45 to 75 years old;
- Signed informed consent
Key exclusion criteria (15 listed)
- Individuals with cardiovascular risk factors on drug treatment (dyslipidemia, hypertension, Diabetes Mellitus);
- Individuals with Metabolic Syndrome;
- Individuals with familiar background of premature cardiovascular disease;
- Individuals with BMI ≥ 30 kg/m2;
- Women that still maintain your menstrual cycle;
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 |
|---|---|---|
| punicalagin and hydroxytyrosol mixtureAlso: Punicalagin and hydroxytyrosolAntioxidant Supplement (punicalagin and hydroxytyrosol mixture) During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity. | Dietary supplement | Antioxidant supplement |
| Control supplement (maltodextrin)Also: MaltodextrinDuring one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity. | Dietary supplement | Control supplement |
Primary outcome
Change in the Inflammatory markers after 8 weeks treatment
Time frame: 0, 8, 12 and 20 weeks
Inflammatory markers (Fibrinogen, gelsolin, thrombospondin, interleukin 6 and PCR) will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II
8 secondary outcomes
Change in Oxidative Stress Parameters
Time frame: 0, 8, 12 and 20 weeks
Change in Glucose Metabolism
Time frame: 0, 8, 12 and 20 weeks
Change in Lipid profile
Time frame: 0, 8, 12 and 20 weeks
Change in Endothelial function
Time frame: 0, 8, 12 and 20 weeks
Change in Coagulation markers
Time frame: 0, 8, 12 and 20 weeks
Change in Anthropometric and body composition parameters
Time frame: 0, 8, 12 and 20 weeks
Adverse effects
Time frame: 0 to 20 weeks
Adherence and Tolerance Parameters
Time frame: 0 to 20 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 23 Jan 2014.
- Institute for Health Research IdiPAZLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing punicalagin and hydroxytyrosol mixture in people with Healthy, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 15 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 23 Jan 2014. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in the Inflammatory markers after 8 weeks treatment (time frame: 0, 8, 12 and 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2014.