HealthyNCT03611114
The Impact of Citrus Products on Cardiovascular Health
A study testing Blood orange juice in people with Healthy and Overweight and Obesity, run by University of Leeds at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight and Obesity
- What is being tested?
- Blood orange juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2017to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Caucasians (of European origin)
- BMI > 25 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Blood Orange Juice Consumption on Endothelial Function in Healthy Overweight/Obese Men and Premenopausal Women of European Origin
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.
Read the 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.
- Conditions
- Healthy, Overweight and Obesity
- Being tested
- Blood orange juice, Control drink
- Keywords
- endothelial function, flow mediated dilation, lipid profile, blood pressure, flavanones, Caucasian
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood orange juiceDietary supplement
Control drinkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Blood orange juice | Experimental | Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks. Receives: Dietary Supplement: Blood orange juice |
| Control drink | Placebo comparator | Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks. Receives: Dietary Supplement: Control drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Blood pressure will be measured prior to and following 2-week consumption of either blood orange juice or a control drink.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start10 Jan 2017
- Primary completion21 Jun 2017
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Birch, University of Leeds
- Investigators
- Lu Li, PhD, Principal investigator, University of LeedsKaren M Birch, PhD, Study director, University of LeedsChristine Bosch, PhD, Study chair, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611114
- Sponsor's protocol ID
- BIOSCI 15-030
- Status last verified
- Jul 2019
- First submitted
- 18 Apr 2018
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12881205Perticone 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.
PubMed 11147782Thijssen 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.
PubMed 20952670Li 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.
PubMed 32510144
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Orange Juice Consumption on Endothelial Function in Healthy Overweight/Obese Men and Premenopausal Women of European Origin
- ClinicalTrials.gov ID
- NCT03611114
- Acronym / sponsor ID
- BIOSCI 15-030
- Conditions
- Healthy, Overweight and Obesity
- Keywords
- endothelial function, flow mediated dilation, lipid profile, blood pressure, flavanones, Caucasian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood orange juice | Experimental | Dietary Supplement: Blood orange juiceSubjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks. |
| Control drink | Placebo comparator | Dietary Supplement: Control drinkSubjects will be asked to consume a control drink (400 ml/day) for 2 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy
- Caucasians (of European origin)
- BMI > 25 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood orange juice | Dietary supplement | Blood orange juice |
| Control drink | Dietary supplement | Control drink |
Primary outcome
Changes in flow mediated dilation between baseline and endpoint within the intervention group vs. control group
Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
FMD will be evaluated prior to and following 2-week consumption of either blood orange juice or a control drink.
7 secondary outcomes
Changes in blood pressure between baseline and endpoint within the intervention group vs. control group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Background: PubMed 12881205Muller-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.
- Background: PubMed 11147782Perticone 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.
- Background: PubMed 20952670Thijssen 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.
- Derived from this study: PubMed 32510144Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Li, PhD principal investigator
University of Leeds
Karen M Birch, PhD study director
University of Leeds
Christine Bosch, PhD study chair
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood orange juice in people with Healthy and Overweight and Obesity, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in flow mediated dilation between baseline and endpoint within the intervention group vs. control group (time frame: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611114, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.