The Impact of Citrus Products on Cardiovascular Health

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611114
• Other study ID #: BIOSCI 15-030
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: July 2019
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 30, 2018
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Blood orange juice

• Control drink

Locations

Country	Name	City	State
United Kingdom	University of Leeds	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.