High LDL-cholesterol Levels Clinical Trial
— AppleCorOfficial title:
Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors: Innovation in Crop and Application to Health.
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins, and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink.
| Status | Not yet recruiting |
| Enrollment | 120 |
| Est. completion date | February 2020 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Men and women over 18 years old. - LDL-cholesterol levels =115 mg/dl and =190 mg/dl. - Sign the informed consent provided before the initial screening visit. Exclusion Criteria: - LDL-cholesterol levels =115 mg/dl and <190 mg/dl. - Use of hypolipemiant treatment (drugs and functional foods), or hypoglucaemiant treatment. - Having diabetes mellitus type 1 or type 2. - BMI values =35kg/m2. - Present triglycerides levels =350mg/dl. - Presenting anemia (hemoglobin =13g/dl in men and =12g/dl in women). - Subjects diagnosed of intestinal disorders such as Chron disease, colitis ulcerous, celiac disease and irritable bowel syndrome. - Present fructose and/or sorbitol and/or gluten intolerance. - Present clinical active chronic disease - Use of antioxidants supplements. - Being pregnant or intending to become pregnant. - Be in breastfeeding period. - Present chronic alcoholism. - Tobacco use. - Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study. - Being unable to follow the study guidelines. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | University Rovira i Virgili | Reus | Tarragona |
| Lead Sponsor | Collaborator |
|---|---|
| University Rovira i Virgili | Ministerio de Ciencia e Innovación, Spain, Universitat de Lleida |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in serum LDL-cholesterol (measured in mg/dL) | Serum lipids will be measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). Then, LDL-cholesterol will be alculated by the Friedewald formula. | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in parameters of body composition (weight measured in kg) | Trained dieticians measure weight using a body composition analyzer (Tanita SC 330-S; Tanita Corp., Barcelona, Sapin) | 6 weeks, week 1, week 2, week 4 and week 6 | |
| Secondary | Parameters of body composition (height measured in meters) | Trained dieticians measure height using a well mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain). | 6 weeks, week 1 | |
| Secondary | Changes in parameters of body composition (BMI measured in kg/m2) | Body mass index (BMI) is calculated as the ratio between measured weight (kg)/and the square of height (m). | 6 weeks, week 1, week 2, week 4 and week 6 | |
| Secondary | Changes in parameters of body composition (waist circumference measured in cm) | Waist circumference (WC) is measured at the umbilicus using a 150 cm anthropometric steel measuring tape. | 6 weeks, week 1, week 2, week 4 and week 6 | |
| Secondary | Changes in blood pressure (systolic blood pressure and diastolic blood pressure measured in mmHg) | Systolic and diastolic blood pressure (SBP and DBP) are measured twice after 2-5 minutes of patient seated, with one-minute interval in between, using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain). | 6 weeks, week 1, week 2, week 4 and week 6 | |
| Secondary | Changes in ischemic reactive hyperemia (IRH measured in perfusion units) | The endothelial-dependent vasomotor functions will be measured as IRH by a Laser-Doppler linear Periflux 5000 flowmeter (Perimed AB, Järfälla, Stockholm, Sweden) | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in lipid plasmatic markers (total cholesterol, HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100 and Apo A. All these lipid plasmatic markers will be measured in mg/dL) | Total cholesterol, HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100 and Apo A will be measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in glucose markers (glucose and insulin measured in mg/dL) | measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in oxidative markers (LDLox and Endogenous fat soluble antioxidants measured in mg/dL) | Plasma oxidized LDL measured by ELISA kit (Mercodia AB, Uppsala, Sweden). The analysis of fat-soluble vitamins (vitamin D, alpha-tocopherol, and carotenoids) will be carried out in whole blood with DBS cards. The determinations will be performed by ultra-performance liquid chromatography (UPLC) coupled to photodiode array (PDA) and tandem mass spectrometry (MS/MS) detectors. | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in inflammation markers (c-reactive protein and serum endothelin-1 measured in mg/dL) | Serum high sensitive C reactive measured by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). Serum endothelin type 1 measured by ELISA kits (R&D Systems, Minneapolis, USA). | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in dietary compliance markers (Phenolic compounds and metabolites measured in mg/L in 24h urine samples) | will be analysed by UPLC-MS/MS as previously described. | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in faeces metabolites (Short Chain Fatty Acids, bile acids and sterols measured in mg/L in faeces samples) | will be performed by gas chromatography (GC). | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in fecal microbiota composition (relative abundance of the identified operational taxonomic units (OTUs) measured as % change from baseline) | will be studied by sequencing its whole genomic content. Illumina platform will be used to obtain the metagenomics and metatranscriptomics of each sample following previous protocols developed. | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in lipoprotein profile (number of LDL and HDL particles measured as % change from baseline) | Number of particles and size LDL and HDL measured by NMR technology, in a Vantera Clinical Analyzer (LipoScience Inc., Raleigh, NC, USA). | 6 weeks, week 1 and week 6 | |
| Secondary | Changes in cholesterol efflux (measured as % change from baseline) | Cholesterol efflux measured by in vitro assays in Murine J-774A.1 macrophages labeled with TopFluor-Cholesterol, a fluorescent cholesterol probe in which the cholesterol molecule is linked to boron dipyrromethene difluoride (BODIPY) moiety (Avanti Polar Lipids, USA). | 6 weeks, week 1 and week 6 |