Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

Healthy Clinical Trial

— PROBELTEII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042742
• Other study ID #: PROBELTEII
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2013
• Last updated: January 20, 2014
• Start date: April 2013
• Est. completion date: October 2013

Study information

• Verified date: January 2014
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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, ?-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Inflammatory markers after 8 weeks treatment	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	0, 8, 12 and 20 weeks	Yes
Secondary	Change in Oxidative Stress Parameters	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.	0, 8, 12 and 20 weeks	Yes
Secondary	Change in Glucose Metabolism	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	0, 8, 12 and 20 weeks	Yes
Secondary	Change in Lipid profile	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	0, 8, 12 and 20 weeks	No
Secondary	Change in Endothelial function	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	0, 8, 12 and 20 weeks	Yes
Secondary	Change in Coagulation markers	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	0, 8, 12 and 20 weeks	No
Secondary	Change in Anthropometric and body composition parameters	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	0, 8, 12 and 20 weeks	No
Secondary	Adverse effects	Parameters measured were: transaminases and creatinine. Will be evaluated during all the study visits	0 to 20 weeks	Yes
Secondary	Adherence and Tolerance Parameters	Parameters measured were: adherence and tolerance to the products. Will be evaluated during all study visits.	0 to 20 weeks	No

External Links

•   Institute for Health Research IdiPAZ
•   Research group in Nutrition and Functional Foods (NUTRINVEST)