Clinical trial NCT01290250: Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans
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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: The Coca-Cola Company
Sponsor class: INDUSTRY
First posted: 2011-02-04
Enrollment: 210
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 3 months
measure: Fasting Plasma Insulin Concentration
timeFrame: 3 months
measure: Fasting Plasma Triacylglycerols Concentration
timeFrame: 3 months
measure: Fasting Plasma High-Density Lipoprotein Cholesterol Concentration
timeFrame: 3 months
measure: Insulin resistance using HOMA (Homeostatic Model Assessment)index
timeFrame: 3 months
measure: Fasting Plasma glucose concentrations
timeFrame: 3 months
measure: Diastolic blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: Antioxidant defense system
timeFrame: 3 months
measure: Biomarkers of inflammation
timeFrame: 3 months
measure: Biomarkers of cardiovascular risk.
timeFrame: 3 months
measure: Metabolic analysis
timeFrame: 3 months
measure: Gene expression analysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of
Study officials:
affiliation: Universidad de Granada
name: Concepcion Aguilera, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Granada
name: Maria Dolores Mesa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Granada
name: Angel Gil, PhD
role: STUDY_CHAIR
References:
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.