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

Coca-Cola

Status: Completed

Conditions: Overweight; Obesity

Treatments: Other: Orange juice based beverage enriched in polyphenols

Study type: Interventional

Funder types: Industry

Identifiers

NCT01290250

BIONAOS-ORANGE

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups, including a placebo group

Orange juice based beverage enriched in polyphenols

Experimental group

Description:

2 daily doses (250 ml each) during 3 months

Treatment:

Other: Orange juice based beverage enriched in polyphenols

Orange juice with low levels of polyphenols

Placebo Comparator group

Description:

2 daily doses (250 ml each) during 3 months

Treatment:

Other: Orange juice based beverage enriched in polyphenols