OverweightBIONAOSNCT01290250
Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans
A study testing Orange juice based beverage enriched in polyphenols in people with Overweight and Obesity, run by The Coca-Cola Company at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Orange juice based beverage enriched in polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of
Granada, Granada, 18071
About this study
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
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.
- Conditions
- Overweight, Obesity
- Being tested
- Orange juice based beverage enriched in polyphenols
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juice based beverage enriched in polyphenolsOther
2 daily doses (250 ml each) during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Orange juice based beverage enriched in polyphenols | Experimental | 2 daily doses (250 ml each) during 3 months Receives: Other: Orange juice based beverage enriched in polyphenols |
| Orange juice with low levels of polyphenols | Placebo comparator | 2 daily doses (250 ml each) during 3 months Receives: Other: Orange juice based beverage enriched in polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured: 3 months
Fasting Plasma Insulin Concentration
Measured: 3 months
Fasting Plasma Triacylglycerols Concentration
Measured: 3 months
Fasting Plasma High-Density Lipoprotein Cholesterol Concentration
Measured: 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
Measured: 3 months
Fasting Plasma glucose concentrations
Measured: 3 months
Diastolic blood pressure
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Coca-Cola Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Concepcion Aguilera, Universidad de Granada
- Investigators
- Concepcion Aguilera, Phd, Principal investigator, Universidad de GranadaMaria Dolores Mesa, PhD, Principal investigator, Universidad de GranadaAngel Gil, PhD, Study chair, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290250
- Sponsor's protocol ID
- BIONAOS-ORANGE
- Acronym
- BIONAOS
- Status last verified
- Mar 2013
- First submitted
- 21 Dec 2010
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26136593
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01290250
- Acronym / sponsor ID
- BIONAOS / BIONAOS-ORANGE
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- The Coca-Cola CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange juice based beverage enriched in polyphenols | Experimental | Other: Orange juice based beverage enriched in polyphenols2 daily doses (250 ml each) during 3 months |
| Orange juice with low levels of polyphenols | Placebo comparator | Other: Orange juice based beverage enriched in polyphenols2 daily doses (250 ml each) during 3 months |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juice based beverage enriched in polyphenols2 daily doses (250 ml each) during 3 months | Other | Orange juice based beverage enriched in polyphenols, Orange juice with low levels of polyphenols |
Primary outcome
Systolic blood pressure
Time frame: 3 months
Fasting Plasma Insulin Concentration
Time frame: 3 months
Fasting Plasma Triacylglycerols Concentration
Time frame: 3 months
Fasting Plasma High-Density Lipoprotein Cholesterol Concentration
Time frame: 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
Fasting Plasma glucose concentrations
Time frame: 3 months
Diastolic blood pressure
Time frame: 3 months
5 secondary outcomes
Antioxidant defense system
Time frame: 3 months
Biomarkers of inflammation
Time frame: 3 months
Biomarkers of cardiovascular risk.
Time frame: 3 months
Metabolic analysis
Time frame: 3 months
Gene expression analysis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Derived from this study: PubMed 26136593Rangel-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Concepcion Aguilera, Phd principal investigator
Universidad de Granada
Maria Dolores Mesa, PhD principal investigator
Universidad de Granada
Angel Gil, PhD study chair
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice based beverage enriched in polyphenols in people with Overweight and Obesity, run by The Coca-Cola Company at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01290250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013.