An interventional study of Blood orange juice and Control drink in Healthy and Overweight and Obesity, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by University of Leeds · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 16 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
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Exclusion Criteria:
Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks.
Dietary Supplement: Blood orange juice
Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks.
Dietary Supplement: Control drink
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.
Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
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Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Leeds