The Impact of Citrus Products on Cardiovascular Health
Effects of Blood Orange Juice Consumption on Endothelial Function in Healthy Overweight/Obese Men and Premenopausal Women of European Origin
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jan 2017
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2017
CompletedFirst Submitted
Initial submission to the registry
April 18, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2018
CompletedJuly 19, 2019
July 1, 2019
5 months
April 18, 2018
July 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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.
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.
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.
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.
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.
- +2 more secondary outcomes
Study Arms (2)
Blood orange juice
EXPERIMENTALSubjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks.
Control drink
PLACEBO COMPARATORSubjects will be asked to consume a control drink (400 ml/day) for 2 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Generally healthy
- Caucasians (of European origin)
- BMI \> 25 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Leeds
Leeds, LS2 9JT, United Kingdom
Related Publications (4)
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.
PMID: 12881205BACKGROUNDPerticone 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.
PMID: 11147782BACKGROUNDThijssen 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.
PMID: 20952670BACKGROUNDLi 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.
PMID: 32510144DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
April 18, 2018
First Posted
August 2, 2018
Study Start
January 10, 2017
Primary Completion
June 21, 2017
Study Completion
August 30, 2018
Last Updated
July 19, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share