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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Orange juice based beverage enriched in polyphenols
Sponsored by
The Coca-Cola Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Orange juice based beverage enriched in polyphenols

Orange juice with low levels of polyphenols

Arm Description

2 daily doses (250 ml each) during 3 months

2 daily doses (250 ml each) during 3 months

Outcomes

Primary Outcome Measures

Systolic blood pressure
Fasting Plasma Insulin Concentration
Fasting Plasma Triacylglycerols Concentration
Fasting Plasma High-Density Lipoprotein Cholesterol Concentration
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
Fasting Plasma glucose concentrations
Diastolic blood pressure

Secondary Outcome Measures

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.
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)
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).
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
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

Full Information

First Posted
December 21, 2010
Last Updated
March 14, 2013
Sponsor
The Coca-Cola Company
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1. Study Identification

Unique Protocol Identification Number
NCT01290250
Brief Title
Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Coca-Cola Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orange juice based beverage enriched in polyphenols
Arm Type
Experimental
Arm Description
2 daily doses (250 ml each) during 3 months
Arm Title
Orange juice with low levels of polyphenols
Arm Type
Placebo Comparator
Arm Description
2 daily doses (250 ml each) during 3 months
Intervention Type
Other
Intervention Name(s)
Orange juice based beverage enriched in polyphenols
Intervention Description
2 daily doses (250 ml each) during 3 months
Primary Outcome Measure Information:
Title
Systolic blood pressure
Time Frame
3 months
Title
Fasting Plasma Insulin Concentration
Time Frame
3 months
Title
Fasting Plasma Triacylglycerols Concentration
Time Frame
3 months
Title
Fasting Plasma High-Density Lipoprotein Cholesterol Concentration
Time Frame
3 months
Title
Insulin resistance using HOMA (Homeostatic Model Assessment)index
Description
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
Time Frame
3 months
Title
Fasting Plasma glucose concentrations
Time Frame
3 months
Title
Diastolic blood pressure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Antioxidant defense system
Description
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.
Time Frame
3 months
Title
Biomarkers of inflammation
Description
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)
Time Frame
3 months
Title
Biomarkers of cardiovascular risk.
Description
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).
Time Frame
3 months
Title
Metabolic analysis
Description
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
Time Frame
3 months
Title
Gene expression analysis
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Concepcion Aguilera, Phd
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Dolores Mesa, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angel Gil, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26136593
Citation
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.
Results Reference
derived

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

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