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The purpose of this study is to evaluate the effects of a new orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones) on features of metabolic syndrome and cardiovascular disease risk factors related to inflammation and antioxidant defense system in overweight and obese adult humans. This study hypothesizes that consumption of an orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure and the Homeostatic Model Assessment (HOMA) index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orange juice based beverage enriched in polyphenols | Experimental | 2 daily doses (250 ml each) during 3 months |
|
| Orange juice with low levels of polyphenols | Placebo Comparator | 2 daily doses (250 ml each) during 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orange juice based beverage enriched in polyphenols | Other | 2 daily doses (250 ml each) during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | 3 months | |
| Fasting Plasma Insulin Concentration | 3 months | |
| Fasting Plasma Triacylglycerols Concentration | 3 months | |
| Fasting Plasma High-Density Lipoprotein Cholesterol Concentration | 3 months | |
| Insulin resistance using HOMA (Homeostatic Model Assessment)index | The HOMA index will be calculated as the product of the fasting plasma insulin level (mU/mL) and the fasting plasma glucose level (mmol/L), divided by 22.5 | 3 months |
| Fasting Plasma glucose concentrations | 3 months | |
| Diastolic blood pressure | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antioxidant defense system | Biomarkers of the non-enzymatic (NE-ADS) and enzymatic antioxidant defense system (E-ADS). For the NE-ADS, in addition to total plasma antioxidant capacity, malondialdhyde, and total carbonyl protein derivatives, plasma α-tocopherol, β-carotene, retinol, coenzyme Q and total blood glutathione will be determined. Furthermore, the amount of plasma oxidized LDL and urinary 8-hydroxy-2'-deoxyguanosine and F2-isoprostanes will be measured. For E-ADS the activities of glutathione reductase, glutathione peroxidase, superoxide dismutase, and catalase in red blood cells will be assessed. |
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Inclusion Criteria:
and having altered at least two markers of MS namely:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Concepcion Aguilera, Phd | Universidad de Granada | Principal Investigator |
| Maria Dolores Mesa, PhD | Universidad de Granada | Principal Investigator |
| Angel Gil, PhD | Universidad de Granada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of | Granada | Granada | 18071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26136593 | Derived | Rangel-Huerta OD, Aguilera CM, Martin MV, Soto MJ, Rico MC, Vallejo F, Tomas-Barberan F, Perez-de-la-Cruz AJ, Gil A, Mesa MD. Normal or High Polyphenol Concentration in Orange Juice Affects Antioxidant Activity, Blood Pressure, and Body Weight in Obese or Overweight Adults. J Nutr. 2015 Aug;145(8):1808-16. doi: 10.3945/jn.115.213660. Epub 2015 Jul 1. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D059808 | Polyphenols |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 3 months |
| Biomarkers of inflammation | Biomarkers of inflammation: Interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), matrix metalloproteinase-9 (MMP-9), monocyte chemotactic protein 1 (MCP-1)and polymorphonuclear neutrophils myeloperoxidase (MPO) | 3 months |
| Biomarkers of cardiovascular risk. | Biomarkers of cardiovascular risk:soluble endothelial selectin (sE-selectin), soluble intercellular adhesion molecule 1 (sICAM-1), soluble vascular cell adhesion molecule (sVCAM-1), total and active tissue plasminogen activator inhibitor-1 (tPAI-1), tumor necrosis factor alpha (TNF-α). | 3 months |
| Metabolic analysis | Gastrointestinal hormones involved in the control of satiety and insulin secretion i.e. active amylin, ghrelin (GHR), glucagon peptide-1 (GLP-1), gastric inhibitory peptide or gastric insulinotropic peptide (GIP), polypeptide YY 3-36, pancreatic polypeptide (PP). Likewise, adiponectin, leptin, resistin, visfatin, hepatocyte growth factor (HGF), nerve growth factor (NGF), retinol binding protein 4 (RBP4) and L-fatty acid binding protein (L-FABP) will be determined | 3 months |
| Gene expression analysis | Whole genome gene expression analysis: This analysis will be carried out in a subset of 20 control and 20 experimental samples at four times: 160 arrays. The GeneChip® Human Exon 1.0 ST will be used for the gene expression analysis. Validation by Reverse transcription polymerase chain reaction (RTPCR): In order to confirm the arrays results, a total of 93 differentially expressed genes in the experimental samples will be analyzed by RTPCR using low density arrays | 3 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |