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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood orange juice | Experimental | Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks. |
|
| Control drink | Placebo Comparator | Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood orange juice | Dietary Supplement |
| ||
| Control drink |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lu Li, PhD | University of Leeds | Principal Investigator |
| Karen M Birch, PhD | University of Leeds | Study Director |
| Christine Bosch, PhD | University of Leeds | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leeds | Leeds | LS2 9JT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12881205 | Background | 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. doi: 10.1152/ajpheart.00966.2002. Epub 2003 Jul 24. | |
| 11147782 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2017 | May 11, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2017 | May 11, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
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. |
| 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. doi: 10.2337/diabetes.50.1.159. |
| 20952670 | Background | 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. |
| 32510144 | Derived | Li L, Lyall GK, Martinez-Blazquez JA, Vallejo F, A Tomas-Barberan F, Birch KM, Boesch C. Blood Orange Juice Consumption Increases Flow-Mediated Dilation in Adults with Overweight and Obesity: A Randomized Controlled Trial. J Nutr. 2020 Sep 1;150(9):2287-2294. doi: 10.1093/jn/nxaa158. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |