Healthy
Conditions
Keywords
Cross-over studies, Antioxidants, Hydroxytyrosol, Punicalagin, Treatment outcome, Inflammatory markers, Endothelial function, Humans, Adults, volunteers
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.
Interventions
DIETARY_SUPPLEMENTpunicalagin 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.
DIETARY_SUPPLEMENTControl 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.
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 |
| 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. |
| 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 |
Countries
Spain
Outcome results
None listed