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Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

NCT02042742 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2014-01-23

No results posted yet for this study

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. 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

Interventions

DIETARY_SUPPLEMENT

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.

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.

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02042742 on ClinicalTrials.gov