Clinical trial NCT02042742: Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Cross-over studies
Antioxidants
Hydroxytyrosol
Punicalagin
Treatment outcome
Inflammatory markers
Endothelial function
Humans
Adults
volunteers
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 76
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Change in the Inflammatory markers after 8 weeks treatment
timeFrame: 0, 8, 12 and 20 weeks
Secondary outcomes:
measure: Change in Oxidative Stress Parameters
timeFrame: 0, 8, 12 and 20 weeks
measure: Change in Glucose Metabolism
timeFrame: 0, 8, 12 and 20 weeks
measure: Change in Lipid profile
timeFrame: 0, 8, 12 and 20 weeks
measure: Change in Endothelial function
timeFrame: 0, 8, 12 and 20 weeks
measure: Change in Coagulation markers
timeFrame: 0, 8, 12 and 20 weeks
measure: Change in Anthropometric and body composition parameters
timeFrame: 0, 8, 12 and 20 weeks
measure: Adverse effects
timeFrame: 0 to 20 weeks
measure: Adherence and Tolerance Parameters
timeFrame: 0 to 20 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: