Metabolic syndrome Nutritional, Metabolic, Endocrine
Conditions
Interventions
Thirty-two subjects with risk factors for metabolic syndrome will be enrolled and randomized using a computer random number generator to consume 240 ml/day of a wild blueberry drink (providing at leas
Sponsors
University of Milan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women and men 2. Aged 40-65 years 3. Body mass index 25-30 kg/m² 4. Waist circumference =102 cm in men and =88 cm in women 5. High density lipoprotein cholesterol < 1.04 mmol/l in men and <1.30 mmol/l in women 6. Serum triglycerides =1.7 mmol/l or treatment with triglycerides-lowering drugs 7. Systolic blood pressure =130 mmHg or diastolic blood pressure =85 mmHg or treatment with blood pressure lowering drugs 8. Serum glucose =6.1 mmol/l or treatment with blood glucose-lowering drugs 9. No smokers
Exclusion criteria
Exclusion criteria: 1. Obesity 2. Uncontrolled diabetes 3. Primary hypercholesterolemia 4. Dysthyroidism 5. Liver and renal disease 6. Gastrointestinal disorders 7. Antibiotic treatment 8. Use of supplements 9. Impaired cognitive function 10. Smokers 11. Allergy to blueberry and their products 12. Vegetarian, vegans, macrobiotic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute study: improvement of vascular function measured as reactive hyperemia index (by EndPAT2000) at baseline and 2 hours after the intake of blueberry or placebo treatments Chronic study: improvement of vascular function measured as reactive hyperemia index (by EndPAT2000) at baseline and after 8-week treatment with blueberry or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| The following list of markers will be measured at baseline (T0) and after 8 weeks (T8) of blueberry and/or placebo treatment: 1. Vascular function markers: vascular endothelial growth factor, vascular cell adhesion molecule-1, E-selectin, endothelin-1, endothelial nitric oxide/inducible nitric oxide measured in serum by ELISA kits 2. Digital augmentation index measured by EndoPAT2000 3. Blood pressure measured by a sphygmomanometer 4. Endothelial permeability markers: vascular endothelial cadherin, occludin, claudin 5 measured in serum by ELISA kits 5. Oxidative stress markers: endogenous and oxidatively-induced DNA damage measured in the buffy coat from blood by the comet assay 6. Inflammatory markers: tumor necrosis factor-alpha, interleukin-6, C-reactive protein measured in serum by ELISA kits 7. Intestinal permeability marker: serum and fecal zonulin measured by ELISA kits 8. Cardiometabolic markers: triglycerides, total serum cholesterol, low- and high-density lipoprotein cholesterol, glucose, insulin, c-peptide measured in plasma/serum by standardized techniques 9. Hepatic and renal function: serum creatinine, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase measured in plasma/serum by standardized techniques 10. Nutritional markers: anthocyanins (ACNs), vitamin C, folate, vitamin B12, measured in plasma/serum by high performance liquid chromatography mass spectrometry (HPLC/MS); glutathione (GSH/GSSG) measured in plasma/serum by ELISA kits 11. Food intake estimated by the use of food diaries and analysed by Metadieta software 12. Lipidomic, proteomic and metabolomic status measured in the buffy coat from blood using omics approaches (e.g., proteomic, lipidomic, metabolomic) | — |
Countries
Italy
Outcome results
None listed