The Impact of Citrus Products on Cardiovascular Health

Not Applicable

Completed

• Conditions: Overweight and Obesity; Healthy
• Interventions: Dietary Supplement: Control drink; Dietary Supplement: Blood orange juice

• Registration Number: NCT03611114
• Lead Sponsor: University of Leeds

Brief Summary

Epidemiological studies have indicated that the consumption of citrus fruit is inversely associated with the risk of cardiovascular disease. However, clinical data regarding the effects of blood orange juice upon endothelial function is scarce. This randomised, crossover study investigates whether blood orange juice compared to a control drink improves blood vessel function and other cardiovascular health indicators (such as blood pressure and blood lipids). All the subjects will be asked to consume blood orange juice and a control drink in a randomised order, each over a 2-week period, divided by a 1-week wash out period.

Detailed Description

Endothelial function measured via flow mediated dilation (FMD), blood pressure, anthropometric measures, lipid profile, high-sensitivity C-reactive protein (hsCRP) and endothelin 1 (ET-1), cyclic guanosine monophosphate (cGMP) will be evaluated in healthy overweight/obese Caucasians prior to and following 2-week consumption of blood orange juice and a control drink. Evaluation of endothelial function as measured by FMD will be conducted on specific days of the menstrual cycle to minimise the fluctuation in oestrogen levels in premenopausal women, which will be monitored in serum samples.

Study Timeline

• Study Start: 2017-01-10
• Primary Completion: 2017-06-21
• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-02
• Study Completion: 2018-08-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Generally healthy
• Caucasians (of European origin)
• BMI > 25 kg/m2

Exclusion Criteria

• Presence of cardiovascular diseases
• Smoking
• Use of medications or dietary supplements (vitamins, antioxidants)
• On a special diet and/or a training program to change weight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control drink	Control drink	Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks.
Blood orange juice	Blood orange juice	Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in flow mediated dilation between baseline and endpoint within the intervention group vs. control group	Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.	FMD will be evaluated prior to and following 2-week consumption of either blood orange juice or a control drink.

Secondary Outcome Measures

Name	Time	Method
Changes in blood pressure between baseline and endpoint within the intervention group vs. control group	Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.	Blood pressure will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Changes in flavanone metabolites between baseline and endpoint within the intervention group vs. control group	Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.	Flavanone metabolites will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Changes in high sensitivity C-reactive protein between baseline and endpoint within the intervention group vs. control group	Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.	Serum hsCRP will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Changes in lipid profile between baseline and endpoint within the intervention group vs. control group	Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.	Serum total cholesterol, HDL cholesterol, LDL cholesterol will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Changes in endothelin-1 (ET-1) between baseline and endpoint within the intervention group vs. control group	Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.	Serum ET-1 will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Changes in oestradiol between baseline and endpoint within the intervention group vs. control group	Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.	Serum oestradiol will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Changes in cyclic guanosine monophosphate (cGMP) between baseline and endpoint within the intervention group vs. control group	Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.	Cyclic guanosine monophosphate (cGMP) will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.

Trial Locations

Locations (1)

University of Leeds; 🇬🇧 Leeds, United Kingdom