Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Antioxidant supplement

Treatment consist of consuming 65g of punicalagin and 3,3g of hydroxytyrosol (plus 331,7g of maltodextrin) three times daily, during 8 weeks.

Group Type EXPERIMENTAL

punicalagin and hydroxytyrosol mixture

Intervention Type DIETARY_SUPPLEMENT

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

Treatment consist of consuming 400g of maltodextrin three times daily, during 8 weeks.

Group Type PLACEBO_COMPARATOR

Control supplement (maltodextrin)

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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punicalagin and hydroxytyrosol mixture

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.

Intervention Type DIETARY_SUPPLEMENT

Control supplement (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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Punicalagin and hydroxytyrosol Maltodextrin

Eligibility Criteria

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Inclusion Criteria

* Men and women from 45 to 75 years old;
* Signed informed consent

Exclusion Criteria

* 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;
* 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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes