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Trial record 4 of 15 for:    hydroxytyrosol

Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers (PROBELTEII)

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ClinicalTrials.gov Identifier: NCT02042742
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: punicalagin and hydroxytyrosol mixture Dietary Supplement: Control supplement (maltodextrin) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers Related With Cardiovascular Disease: a Crossover Study in Healthy Middle-aged Volunteers
Study Start Date : April 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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Arm Intervention/treatment
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.
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.
Other Name: Punicalagin and hydroxytyrosol

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042742


Locations
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Spain
Hospital Universitario La Paz
Madrid, Spain, 28061
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz

Additional Information:
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT02042742     History of Changes
Other Study ID Numbers: PROBELTEII
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Cross-over studies
Antioxidants
Hydroxytyrosol
Punicalagin
Treatment outcome
Inflammatory markers
Endothelial function
Humans
Adults
volunteers

Additional relevant MeSH terms:
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Antioxidants
3,4-dihydroxyphenylethanol
Phenylethyl Alcohol
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents
Platelet Aggregation Inhibitors
Anti-Infective Agents, Local
Disinfectants