Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

Phase 4

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: punicalagin and hydroxytyrosol mixture; Dietary Supplement: Control supplement (maltodextrin)

• Registration Number: NCT02042742
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-12-27
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-20
• Last Update Submitted: 2014-01-20
• Study First Posted: 2014-01-23
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Antioxidant supplement	punicalagin and hydroxytyrosol mixture	Treatment consist of consuming 65g of punicalagin and 3,3g of hydroxytyrosol (plus 331,7g of maltodextrin) three times daily, during 8 weeks.
Control supplement	Control supplement (maltodextrin)	Treatment consist of consuming 400g of maltodextrin three times daily, during 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in the Inflammatory markers after 8 weeks treatment	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

Name	Time	Method
Change in Glucose Metabolism	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 Endothelial function	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 Oxidative Stress Parameters	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 Lipid profile	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 Coagulation markers	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	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	0 to 20 weeks	Parameters measured were: transaminases and creatinine. Will be evaluated during all the study visits
Adherence and Tolerance Parameters	0 to 20 weeks	Parameters measured were: adherence and tolerance to the products. Will be evaluated during all study visits.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain