The Impact of Citrus Products on Cardiovascular Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Blood Orange Juice Consumption on Endothelial Function in Healthy Overweight/Obese Men and Premenopausal Women of European Origin

Conditions
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Healthy, Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Blood orange juice
* Dietary Supplement: Control drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood orange juice<br>Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks. | Dietary Supplement: Blood orange juice<br> <br> |
| Placebo Comparator: Control drink<br>Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks. | Dietary Supplement: Control drink<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, flow mediated dilation, lipid profile, blood pressure, flavanones, Caucasian