- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01290250
Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans (BIONAOS)
Evaluation of a New Orange-Based Beverage Enriched With Polyphenols (Whole Press) on Features of Metabolic Syndrome and Cardiovascular Risk Factors Related to Inflammation and Antioxidant Defense System in Adult Humans
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Granada, Spain, 18071
- Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (BMI) higher than 25 (overweight or obese) but lower than 40 (extreme obesity) or waist circumference higher than 94 cm for men and 80 cm for women,
and having altered at least two markers of MS namely:
- Hypertension (diastolic pressure higher than 85 mmHg but lower than 110 mmHg)
- Hyperglycemia (higher than 100 mg/dl but lower than 130 mg/dl)
- Elevated plasma triacylglycerol concentrations (higher than 150 mg/dl)
- Decreased plasma HDL-c levels (lower than 40 for men and 50 for women)
- Volunteers will be otherwise healthy and without taking any medication aiming to lower either blood lipids, blood pressure or blood glucose concentrations.
Exclusion Criteria:
- The presence of morbid obesity
- Blood pressure higher than 110 mmHg
- Plasma glucose levels higher than 130 mg/dl
- The use of any medication for the control of blood pressure or glucose or lipid metabolism
- Medical history of consumption of hypocaloric diet in the last year
- Disorders of the food conduct
- The presence of familiar dislipemias relatives of genetic character or the denial to take part in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orange juice based beverage enriched in polyphenols
2 daily doses (250 ml each) during 3 months
|
2 daily doses (250 ml each) during 3 months
|
Placebo Comparator: Orange juice with low levels of polyphenols
2 daily doses (250 ml each) during 3 months
|
2 daily doses (250 ml each) during 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure
Time Frame: 3 months
|
3 months
|
|
Fasting Plasma Insulin Concentration
Time Frame: 3 months
|
3 months
|
|
Fasting Plasma Triacylglycerols Concentration
Time Frame: 3 months
|
3 months
|
|
Fasting Plasma High-Density Lipoprotein Cholesterol Concentration
Time Frame: 3 months
|
3 months
|
|
Insulin resistance using HOMA (Homeostatic Model Assessment)index
Time Frame: 3 months
|
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
Time Frame: 3 months
|
3 months
|
|
Diastolic blood pressure
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antioxidant defense system
Time Frame: 3 months
|
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.
|
3 months
|
Biomarkers of inflammation
Time Frame: 3 months
|
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.
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Concepcion Aguilera, Phd, Universidad de Granada
- Principal Investigator: Maria Dolores Mesa, PhD, Universidad de Granada
- Study Chair: Angel Gil, PhD, Universidad de Granada
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIONAOS-ORANGE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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