Hypercholesterolemic patients Nutritional, Metabolic, Endocrine Pure hypercholesterolaemia
Conditions
Interventions
Current interventions as of 23/04/2014:
Randomized, controlled, double-blind, cross-over, single-centre clinical supplementation trial, in which 33 subjects (19 men and 14 women) will be randomised to
Sponsors
Spanish Ministry of Economy and Competitiveness (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/04/2014: 1. Hypercholesterolemic patients (>200 mg/dL) 2. Aged 20-80 years Previous inclusion criteria: 1. Hyperlipidemic patients 2. Patients with low (<40 mg/dL) HDL cholesterol 3. Aged 20-60 years
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/04/2014: 1. Smokers 2. Athletes with PA >3000 kcal/day 3. BMI >35 kg/m2 4. Diabetes, multiple allergies, intestinal diseases 5. Any condition that limits the mobility of the subject making study visits impossible 6. Life threatening illness such as cancer or severe disease with a lowered expected 3 year survival 7. Any other disease or condition that would worsen the adherence to the measurements or treatment Previous exclusion criteria: 1. Intake of antioxidant supplement or acetylsalicylic acid or any other drug with established antioxidative properties 2. Athletes with PA >3000 kcal/week in leisure-time 3. Obesity (BMI > 30 kg/m2) 4. Diabetes, multiple allergies, intestinal diseases 5. Any condition that limits the mobility of the subject making study visits impossible 6. Life threatening illness such as cancer or severe disease with a lowered expected 3 year survival 7. Any other disease or condition that would worsen the adherence to the measurements or treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. HDL functionality: The following parameters will be measured at baseline and before and after each intervention: 1.1. Markers of compliance: Measurement of tyrosol and hydroxytyrosol in spot morning urine will be performed by GC/mass spectrometry 1.2. Parameters of HDL functionality: Isolation of HDL will be done by sequential centrifugation. 2. The following parameters will be measured in isolated HDL: 2.1. Fatty acid content, vitamin E, and total phenolic content in HDL by HPLC-DAD 2.2. Apolipoproteins (Apo)A1, ApoA2, and ApoA4 by ELISA 2.3. Cholesterol esther transfer protein (CETP) and lecitine cholesterol acyl transferase (LCAT) by fluorometry 2.4. Paraoxonase (Organophosphatase activity) PON1) and PAF-AH activities by spectrometry with automated mode 2.5. 3? chlorotyrosine and 3?-nitro-tyrosine by GC/MS 2.6. Bilayer fluidity of HDL will be measured by confocal microscopy. Cholesterol efflux from cells will be measured in culture of macrophages. 3. OMICS Gene expression assay will be performed as previously described. Several candidate genes implicated in the increase of the HDL cholesterol and in the improvement of the HDL functionality in humans will be tested. Candidate genes: ABCA1: ATP-binding cassette, sub-family A (ABC1), member 1; ABCG1: ATP-binding cassette, sub-family G (WHITE), member 1; and ABCG4: ATP-binding cassette, sub-family G (WHITE), member 4 ApoA1: apolipoprotein A- I; and ApoE: apolipoprotein E; LPL: lipoprotein lipase; PAF-AH1B3: platelet-activating factor acetylhydrolase, isoform Ib, gamma subunit 29kDa; PPARalpha: peroxisome proliferator -activated receptor alpha; PPARgamma: peroxisome proliferator-activated receptor gamma; and PBPPAR: PPAR binding protein; RARA: retinoic acid receptor, alpha. Proteomic analyses, by separation with 2-DE (two-dimensional gel electrophoresis) and PMF (protein mass fingerprinting) with MALDI-TOF-MS (matrix -assisted laser desorption/ionization time of flight mass spectrometry ,will be performed in plas | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxidative damage The following parameters will be measured at baseline and before and after each intervention: 1. Plasma lipids will be performed by enzymatic methods in a automated mode. In vivo circulating oxidized LDL and 3? chlorotyrosine derivates in urine will be determined by ELISA 2. Protein carbonyl content (PCC) by spectrometry 3. 8-isoprostane (8-epi PGF2á) 4. 8-hydroxydeoxyguanosine (8-OHdG) by enzyme-linked immunosorbent assay (ELISA) Added 23/04/2014: 5. Endothelial function 6. Intestinal microorganism study | — |
Countries
Spain
Outcome results
None listed