NCT02195934

The Orange Juice and Cardiovascular Disease Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Quadram Institute Bioscience · Academic / Other
• Sex: All
• Age: 25 Years – 84 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the effect of an anthocyanin-rich blood orange juice with a standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD). Participants aged between 25 and 84 years of age will be recruited into a single arm, two way cross-over study based on their waist measurement, with 42 individuals required to complete the study. Participants will each receive two interventions in a randomised order: 500mL blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily for 28 days. Prior to each intervention there will be a 2 week "run in period" where participants will be asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention period, there will be a 3 week wash out period after which the participants will be asked to then drink the other juice for 28 days. The 500 mL of blood orange juice contains approximately 50mg of anthocyanins, whereas the standard juice contains none. Blood samples will be collected for the preparation of plasma and peripheral blood mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations, transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion of anthocyanin metabolites will be quantified. Other measurements will include pulse wave analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements using the TANITA machine which include weight, fat mass, muscle mass, fat percentage, fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral fat rating, and degree of obesity. All measurements and samples will be taken at baseline and post intervention for each phase of the study.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
OTHER	Standard (blonde) orange juice	Consumption of 500ml standard (blonde) orange juice daily for 28 days
OTHER	Blood orange juice	Consumption of 500ml blood orange juice daily for 28 days

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-07-21
• Last updated: 2016-09-05

Locations

1 site across 1 country: United Kingdom