PROBELTEII: Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers

Sponsor

Instituto de Investigación Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT02042742

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Apr 1, 2013

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

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 Names: 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 Names: Maltodextrin

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 Names:

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 Names:

Maltodextrin

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.