- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01935362
Impact of Oranges on Cardiovascular Health
Bioavailability of Flavanones Compounds and Their Impact on Cardiovascular Health
Cardiovascular disease (CVD) is the leading cause of deaths in the Western world. Established risk factors include high LDL cholesterol, high blood pressure and diabetes. Poor blood vessel health is considered a predictor of future CVD risk, but can be reversed. Several different measurements can be used to determine blood vessel health; such as blood pressure (BP), and newer techniques which measure blood flow through the arteries after a blood pressure cuff restricts blood flow for a few minutes in one arm.
Flavonoids are compounds found in plant-based foods, and are associated with a reduced risk of CVD. From the previous studies, there is strong evidence that orange juice and citrus foods which have higher amount of specific citrus flavonoids improved cardiovascular risk factors such as BP and blood vessel health. Absorption of citrus flavonoids occurs in the colon after bacteria breakdown the forms found in food. After the flavonoids are absorbed into the blood they are modification by liver enzymes before they are excreted in the urine. A large range of citrus flavonoid have been found excreted in the urinary, ranging anywhere from 0-57% of the dose. Variation in the potential health effect may reflect the level of the citrus flavonoid absorbed, and this is not often considered in human studies.
This study is a 4-week double-blinded, randomized, cross-over intervention trial using a commercially-available orange juice supplement and a placebo control. The aims of the study are to determine whether orange juice supplements reduce blood pressure and improve blood vessel health after 4 weeks. Furthermore, to determine if there is a relationship between absorption of flavonoids (as measured by urinary excretion) and changes in blood pressure or blood vessel health.
The participants will need to attend 4 sessions on 4 separate study days, every 4 weeks for 12 weeks. On each study day they will have their weight, height, waist circumference, and blood pressure measured. A finger-prick blood sample, using a single-use lancet (Accu-Chek Safe T Pro Plus), will be taken to check the fasting blood glucose level. Blood flow in fingertips will be monitored before and after reducing blood flow in your forearm using a blood pressure cuff (called an EndoPAT). Participants will be asked to collect urine for 24 hr on each of the study days, and to consume the supplements provided daily for two sets of 4 weeks (there will be 4 weeks in the middle without any supplements).
An improvement in blood pressure and/or blood flow will provide evidence that blood vessel health has improved through short-term (4 week) use of a citrus flavonoid supplement
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
West Yorkshire
-
Leeds, West Yorkshire, United Kingdom, LS2 9JT
- School of Food Science and Nutrition, University of Leeds
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- No known cardiovascular disease or diabetes
- Age between 30-60 years
- Heavier than average (Body mass index, BMI ≥ 25 kg/m2)
- Currently non smoker
- Willing to consume orange juice supplements for 2 months
- Male and female are equally eligible as not mentioned on advert
Exclusion Criteria:
- Those who Taken any antibiotics in the 2 months prior to the study
- Those who consume dietary or herbal supplements
- previous surgery on gastrointestinal tract
- Those who currently taking medication
- Current smokers, or ex-smokers ceasing < 3 months ago
- pregnant or breast feeding
- Those with known allergies to the intervention treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
Placebo administered to participant
|
|
Active Comparator: Citrus supplement
Citrus supplement administered to participant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood pressure
Time Frame: Baseline and 4 weeks
|
Change in systolic and diastolic blood pressure
|
Baseline and 4 weeks
|
An improvement in blood flow
Time Frame: Baseline and 4 weeks
|
Change in blood flow using Endo-PAT device
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood glucose
Time Frame: Baseline and 4 weeks
|
Change in blood glucose level in plasma,
|
Baseline and 4 weeks
|
bioavailability of flavanones compounds
Time Frame: Baseline and 4 weeks
|
Change of urine flavanones from the baseline and after 4 weeks of each arm
|
Baseline and 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Abdurrahman M Sweidan, University of Leeds
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEEC 12-025
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.
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