Back to resultsThe Impact of Citrus Products on Cardiovascular Health
Primary Purpose
Healthy, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Blood orange juice
Control drink
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring endothelial function, flow mediated dilation, lipid profile, blood pressure, flavanones, Caucasian
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
Sites / Locations
- University of Leeds
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Blood orange juice
Control drink
Arm Description
Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks.
Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03611114
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
June 21, 2017 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Overweight and Obesity
Keywords
endothelial function, flow mediated dilation, lipid profile, blood pressure, flavanones, Caucasian
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood orange juice
Arm Type
Experimental
Arm Description
Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks.
Arm Title
Control drink
Arm Type
Placebo Comparator
Arm Description
Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blood orange juice
Intervention Type
Dietary Supplement
Intervention Name(s)
Control drink
Primary Outcome Measure Information:
Title
Changes in flow mediated dilation between baseline and endpoint within the intervention group vs. control group
Description
FMD will be evaluated prior to and following 2-week consumption of either blood orange juice or a control drink.
Time Frame
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Secondary Outcome Measure Information:
Title
Changes in blood pressure between baseline and endpoint within the intervention group vs. control group
Description
Blood pressure will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Time Frame
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Title
Changes in lipid profile between baseline and endpoint within the intervention group vs. control group
Description
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.
Time Frame
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Title
Changes in high sensitivity C-reactive protein between baseline and endpoint within the intervention group vs. control group
Description
Serum hsCRP will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Time Frame
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Title
Changes in endothelin-1 (ET-1) between baseline and endpoint within the intervention group vs. control group
Description
Serum ET-1 will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Time Frame
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Title
Changes in oestradiol between baseline and endpoint within the intervention group vs. control group
Description
Serum oestradiol will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Time Frame
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Title
Changes in flavanone metabolites between baseline and endpoint within the intervention group vs. control group
Description
Flavanone metabolites will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Time Frame
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Title
Changes in cyclic guanosine monophosphate (cGMP) between baseline and endpoint within the intervention group vs. control group
Description
Cyclic guanosine monophosphate (cGMP) will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Time Frame
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Li, PhD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen M Birch, PhD
Organizational Affiliation
University of Leeds
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christine Bosch, PhD
Organizational Affiliation
University of Leeds
Official's Role
Study Chair
Facility Information:
Facility Name
University of Leeds
City
Leeds
ZIP/Postal Code
LS2 9JT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12881205
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.
Results Reference
background
PubMed Identifier
11147782
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.
Results Reference
background
PubMed Identifier
20952670
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.
Results Reference
background
PubMed Identifier
32510144
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.
Results Reference
derived
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The Impact of Citrus Products on Cardiovascular Health
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