Impact of Oranges on Cardiovascular Health

NCT01935362 | Completed Phase 1 DMC

• 1 other identifier: MEEC 12-025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Pressure; Endothelial Dysfunction; Cardiovascular Disease Risk Reduction

Keywords

Flavanones; Bioavailability; Blood vessel health; Blood glucose

Outcome Measures

Primary Outcomes (2)

• blood pressure

  Change in systolic and diastolic blood pressure

  Baseline and 4 weeks

• An improvement in blood flow

  Change in blood flow using Endo-PAT device

  Baseline and 4 weeks

Secondary Outcomes (2)

• blood glucose

  Baseline and 4 weeks

• bioavailability of flavanones compounds

  Baseline and 4 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo administered to participant

Dietary Supplement: Placebo

Citrus supplement

ACTIVE COMPARATOR

Citrus supplement administered to participant

Dietary Supplement: Citrus supplement

Interventions

Citrus supplement DIETARY_SUPPLEMENT

Citrus supplement

Placebo DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead
• Dr Andrea Day and Prof Gary Williamson: collaborator

Study Sites (1)

School Of Food Science and Nutrition, University Of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Links

• Click here for more information about this study: Impact of oranges on cardiovascular health

Study Officials

• Abdurrahman M Sweidan

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: September 5, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 1, 2014

Record last verified: 2014-03

Locations

GB (1)