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

NCT01290250 | Completed DMC

• 1 other identifier: BIONAOS-ORANGE
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (5)

• Antioxidant defense system

  3 months

• Biomarkers of inflammation

  3 months

• Biomarkers of cardiovascular risk.

  3 months

• Metabolic analysis

  3 months

• Gene expression analysis

  3 months

Study Arms (2)

Orange juice based beverage enriched in polyphenols

EXPERIMENTAL

2 daily doses (250 ml each) during 3 months

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

Other: Orange juice based beverage enriched in polyphenols

Interventions

Orange juice based beverage enriched in polyphenols OTHER

2 daily doses (250 ml each) during 3 months

Orange juice based beverage enriched in polyphenols; Orange juice with low levels of polyphenols

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Coca-Cola Company: lead

Study Sites (1)

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

Granada, Granada, 18071, Spain

Location

Related Publications (1)

• 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.

  PMID: 26136593 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Polyphenols

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Biochemistry and Molecular Biology

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: February 4, 2011
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2012
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

ES (1)