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

NCT ID: NCT01290250

Last Updated: 2013-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Orange juice based beverage enriched in polyphenols

2 daily doses (250 ml each) during 3 months

Group Type: EXPERIMENTAL

Orange juice based beverage enriched in polyphenols

Intervention Type: OTHER

2 daily doses (250 ml each) during 3 months

Orange juice with low levels of polyphenols

2 daily doses (250 ml each) during 3 months

Group Type: PLACEBO_COMPARATOR

Orange juice based beverage enriched in polyphenols

Intervention Type: OTHER

2 daily doses (250 ml each) during 3 months

Interventions

Orange juice based beverage enriched in polyphenols

2 daily doses (250 ml each) during 3 months

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Coca-Cola Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Concepcion Aguilera

Lecturer of Biochemistry and Molecular Biology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Concepcion Aguilera, Phd

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Maria Dolores Mesa, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Angel Gil, PhD

Role: STUDY_CHAIR

Universidad de Granada

Locations

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

Granada, Granada, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 26136593 (View on PubMed)

Other Identifiers

BIONAOS-ORANGE

Identifier Type: -

Identifier Source: org_study_id