Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2013

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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: Control supplement
    • Treatment consist of consuming 400g of maltodextrin three times daily, during 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • Adverse effects
    • Time Frame: 0 to 20 weeks
    • Parameters measured were: transaminases and creatinine. Will be evaluated during all the study visits
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Instituto de Investigación Hospital Universitario La Paz
  • Provider of Information About this Clinical Study
    • Sponsor

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