Clinical trial NCT03611114: The Impact of Citrus Products on Cardiovascular Health
Official title: Effects of Blood Orange Juice Consumption on Endothelial Function in Healthy Overweight/Obese Men and Premenopausal Women of European Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Overweight and Obesity
Keywords: endothelial function
flow mediated dilation
lipid profile
blood pressure
flavanones
Caucasian
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Changes in flow mediated dilation between baseline and endpoint within the intervention group vs. control group
timeFrame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Secondary outcomes:
measure: Changes in blood pressure between baseline and endpoint within the intervention group vs. control group
timeFrame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
measure: Changes in lipid profile between baseline and endpoint within the intervention group vs. control group
timeFrame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
measure: Changes in high sensitivity C-reactive protein between baseline and endpoint within the intervention group vs. control group
timeFrame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
measure: Changes in endothelin-1 (ET-1) between baseline and endpoint within the intervention group vs. control group
timeFrame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
measure: Changes in oestradiol between baseline and endpoint within the intervention group vs. control group
timeFrame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
measure: Changes in flavanone metabolites between baseline and endpoint within the intervention group vs. control group
timeFrame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
measure: Changes in cyclic guanosine monophosphate (cGMP) between baseline and endpoint within the intervention group vs. control group
timeFrame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
Study officials:
affiliation: University of Leeds
name: Lu Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds
name: Karen M Birch, PhD
role: STUDY_DIRECTOR
affiliation: University of Leeds
name: Christine Bosch, PhD
role: STUDY_CHAIR
References:
citation: 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.
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. doi: 10.2337/diabetes.50.1.159.
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.
citation: 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.