Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans

Obesity Clinical Trial

— BIONAOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290250
• Other study ID #: BIONAOS-ORANGE
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: March 14, 2013
• Start date: February 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2013
• Source: The Coca-Cola Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: July 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Orange juice based beverage enriched in polyphenols
2 daily doses (250 ml each) during 3 months

Locations

Country	Name	City	State
Spain	Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of	Granada

Sponsors (1)

Lead Sponsor	Collaborator
The Coca-Cola Company

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure		3 months	No
Primary	Fasting Plasma Insulin Concentration		3 months	No
Primary	Fasting Plasma Triacylglycerols Concentration		3 months	No
Primary	Fasting Plasma High-Density Lipoprotein Cholesterol Concentration		3 months	No
Primary	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	No
Primary	Fasting Plasma glucose concentrations		3 months	No
Primary	Diastolic blood pressure		3 months	No
Secondary	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 a-tocopherol, ß-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	No
Secondary	Biomarkers of inflammation	Biomarkers of inflammation: Interleukin-1 beta (IL-1ß), 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	No
Secondary	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-a).	3 months	No
Secondary	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	No
Secondary	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	No