Healthy, Overweight and Obesity
Conditions
Keywords
endothelial function, flow mediated dilation, lipid profile, blood pressure, flavanones, Caucasian
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.
Interventions
DIETARY_SUPPLEMENTBlood orange juice
DIETARY_SUPPLEMENTControl drink
Sponsors
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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. |
| 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. |
Countries
United Kingdom
Outcome results
None listed