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Completed

NCT Number: NCT01935362

Impact of Oranges 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

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

School Of Food Science and Nutrition, University Of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citrus supplement

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. blood pressure

    Time frame: Baseline and 4 weeks

    Change in systolic and diastolic blood pressure

  2. An improvement in blood flow

    Time frame: Baseline and 4 weeks

    Change in blood flow using Endo-PAT device

Secondary outcomes

  1. blood glucose

    Time frame: Baseline and 4 weeks

    Change in blood glucose level in plasma,

  2. bioavailability of flavanones compounds

    Time frame: Baseline and 4 weeks

    Change of urine flavanones from the baseline and after 4 weeks of each arm

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Dr Andrea Day and Prof Gary Williamson

Registry information

Official study title

Bioavailability of Flavanones Compounds and Their Impact on Cardiovascular Health

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 5, 2013
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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