The Impact of Citrus Products on Cardiovascular Health
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Blood orange juice Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks. |
Dietary Supplement: Blood orange juice
|
| Placebo Comparator: Control drink Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks. |
Dietary Supplement: Control drink
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Leeds | Leeds | United Kingdom | LS2 9JT |
Sponsors and Collaborators
- University of Leeds
Investigators
- Principal Investigator: Lu Li, PhD, University of Leeds
- Study Director: Karen M Birch, PhD, University of Leeds
- Study Chair: Christine Bosch, PhD, University of Leeds
Study Documents (Full-Text)
More Information
Publications
- Muller-Delp JM, Lubahn DB, Nichol KE, Philips BJ, Price EM, Curran EM, Laughlin MH. Regulation of nitric oxide-dependent vasodilation in coronary arteries of estrogen receptor-alpha-deficient mice. Am J Physiol Heart Circ Physiol. 2003 Nov;285(5):H2150-7. Epub 2003 Jul 24.
- Perticone F, Ceravolo R, Candigliota M, Ventura G, Iacopino S, Sinopoli F, Mattioli PL. Obesity and body fat distribution induce endothelial dysfunction by oxidative stress: protective effect of vitamin C. Diabetes. 2001 Jan;50(1):159-65.
- Thijssen DH, Black MA, Pyke KE, Padilla J, Atkinson G, Harris RA, Parker B, Widlansky ME, Tschakovsky ME, Green DJ. Assessment of flow-mediated dilation in humans: a methodological and physiological guideline. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H2-12. doi: 10.1152/ajpheart.00471.2010. Epub 2010 Oct 15. Review.
- BIOSCI 15-030