Skip to main content
OpenTrials
Completed

NCT Number: NCT02042742

Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario La Paz

Madrid, 28061, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

punicalagin and hydroxytyrosol mixture

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.

Other names: Punicalagin and hydroxytyrosol

Control supplement (maltodextrin)

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.

Other names: Maltodextrin

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Oxidative Stress Parameters

    Time frame: 0, 8, 12 and 20 weeks

    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.

  2. Change in Glucose Metabolism

    Time frame: 0, 8, 12 and 20 weeks

    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

  3. Change in Lipid profile

    Time frame: 0, 8, 12 and 20 weeks

    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

  4. Change in Endothelial function

    Time frame: 0, 8, 12 and 20 weeks

    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

  5. Change in Coagulation markers

    Time frame: 0, 8, 12 and 20 weeks

    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

  6. Change in Anthropometric and body composition parameters

    Time frame: 0, 8, 12 and 20 weeks

    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

  7. Adverse effects

    Time frame: 0 to 20 weeks

    Parameters measured were: transaminases and creatinine. Will be evaluated during all the study visits

  8. Adherence and Tolerance Parameters

    Time frame: 0 to 20 weeks

    Parameters measured were: adherence and tolerance to the products. Will be evaluated during all study visits.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

Effects of Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers Related With Cardiovascular Disease: a Crossover Study in Healthy Middle-aged Volunteers

Acronym: PROBELTEII

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2014
Registry last updated
Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.