The Impact of Citrus Products on Cardiovascular Health

July 18, 2019 updated by: Karen Birch, University of Leeds

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Blood orange juice
Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks.
Dietary supplement: Blood orange juice
PLACEBO_COMPARATOR: Control drink
Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks.
Dietary supplement: Control drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2017

Primary Completion (ACTUAL)

June 21, 2017

Study Completion (ACTUAL)

August 30, 2018

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (ACTUAL)

August 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOSCI 15-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Blood orange juice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe