Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2013-06-30
2014-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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placebo
Placebo administered to participant
Placebo
Citrus supplement
Citrus supplement administered to participant
Citrus supplement
Interventions
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Citrus supplement
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
60 Years
ALL
Yes
Sponsors
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Dr Andrea Day and Prof Gary Williamson
UNKNOWN
University of Leeds
OTHER
Responsible Party
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Abdurrahman M Sweidan
Mr
Principal Investigators
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Abdurrahman M Sweidan
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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School Of Food Science and Nutrition, University Of Leeds
Leeds, West Yorkshire, United Kingdom
Countries
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Related Links
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Click here for more information about this study: Impact of oranges on cardiovascular health
Other Identifiers
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MEEC 12-025
Identifier Type: -
Identifier Source: org_study_id
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