Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers (PROBELTEII)

Instituto de Investigación Hospital Universitario La Paz

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Dietary Supplement: Control supplement (maltodextrin)

Dietary Supplement: punicalagin and hydroxytyrosol mixture

Study type

Interventional

Funder types

Other

Identifiers

NCT02042742

PROBELTEII

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.