AzTrials
AzTrials

Cardiovascular DiseaseOJ & CVDNCT02195934

The Orange Juice and Cardiovascular Disease Study

A study testing Standard (blonde) orange juice and Blood orange juice in people with Cardiovascular Disease, run by Quadram Institute Bioscience at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study aims to compare the effect of an anthocyanin-rich blood orange juice with a standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD). Participants aged between 25 and 84 years of age will be recruited into a single arm, two way cross-over study based on their waist… Read more about this study

Who is it for?
Ages 25 to 84 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
Standard (blonde) orange juice and Blood orange juice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2014to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women aged 25-84 years
  • Waist measurement
  • Caucasians: Men > 102cm (40inches); Women >88cm (34inches)
  • Asians: Men> 90cm (35inches); Women 80cm (31inches)

Who cannot join

  • Those unable to give written informed consent
  • Those unwilling to provide general practitioner (GP) details
  • Regular prescribed medication that may affect study outcome. This will be assessed on an individual basis-not including statins
  • Over-the-counter (non-prescribed) medication that may affect the study data. This will be assessed on an individual basis.
  • Allergy to the test juice drink or the actual fruit itself
  • Chronic medical conditions requiring active treatment. This will be assessed on an individual basis
Show all 36Show fewer
  • Those already consuming blood orange juice, unless they are willing to discontinue consumption for 2 weeks prior to starting the study.
  • Diagnosed diabetics;
  • Peri-menopausal women (defined as: when there is a permanent change in menstrual cycle)
  • Women on hormone replacement therapy (HRT) for less than one year
  • On thyroxine for less than one year
  • Women who are pregnant, have been pregnant within the last 12 months or who are breastfeeding
  • Those taking aspirin (prescribed or self-prescribed)
  • All blood pressure medication
  • Those individuals who happen to be on statins will be excluded if they have been on statins for less than 3 months; or if they are not taking on a daily basis; or those who have recently changed their dosage of statins. This will be assessed on an individual basis
  • Those on regular medication for hypercoagulation and inflammatory conditions e.g. corticosteroids and asthma. The intermittent use of an inhaler will be discussed on an individual basis
  • Those who have had a cardiovascular event such as stroke, myocardial infarction (heart attack) or trans ischemic attacks in the past and deemed unsuitable for participation in the study. This will be discussed with the medical adviser on an individual basis
  • Peripheral vascular disease including claudication
  • Consumption of fish oil supplements (unless participant is willing to discontinue their use 8 weeks prior to the start of the intervention- all other supplements will be assessed on an individual basis
  • Parallel participation in another research project which has involved dietary intervention and/or sampling of blood
  • Any person related to or living with any member of the study team
  • Participation in another research project which involves blood sampling within the last four months unless the total blood from both studies (including this one) does not exceed 470mL)
  • Those who have donated or intend to donate blood within 16 weeks of the first and last study samples
  • Gastrointestinal disease (excluding hiatus hernia) unless symptomatic or study intervention/procedure is contraindicated
  • Those undergoing any on-going clinical investigations with their GP or hospital clinic.
  • Those who have had throat surgery or neck injury
  • Those with internal medical devices
  • Screening exclusion criteria
  • Results of the eligibility screening that indicate or are judged by the Institute of Food Research Human Nutrition Unit (HNU) medical adviser to be indicative of a health problem which could compromise the well-being of the participant if they participated or could affect the study data.
  • BMI <19.5
  • Weight >180kg (28stones)
  • Fasting total cholesterol > 8.0mmol/L
  • Haemoglobin Men <13.8g/dL (8.56mmol/L) Women <12.1g/dL (<5.51mmol/L)
  • Fasting glucose >6mmol/L
  • Blood pressure <90/50mmHg or 95/55mmHg if symptomatic; >160/100mmHg
  • Anyone with any internal medical devices (incompatible with the TANITA)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Institute of Food Research

    Norwich, Norfolk, NR4 7UA

Other trials in United Kingdom

About this study

This study aims to compare the effect of an anthocyanin-rich blood orange juice with a standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD).

Participants aged between 25 and 84 years of age will be recruited into a single arm, two way cross-over study based on their waist measurement, with 42 individuals required to complete the study. Participants will each receive two interventions in a randomised order: 500mL blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily for 28 days.

Read more

Prior to each intervention there will be a 2 week "run in period" where participants will be asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention period, there will be a 3 week wash out period after which the participants will be asked to then drink the other juice for 28 days. The 500 mL of blood orange juice contains approximately 50mg of anthocyanins, whereas the standard juice contains none.

Blood samples will be collected for the preparation of plasma and peripheral blood mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations, transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion of anthocyanin metabolites will be quantified. Other measurements will include pulse wave analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements using the TANITA machine which include weight, fat mass, muscle mass, fat percentage, fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral fat rating, and degree of obesity. All measurements and samples will be taken at baseline and post intervention for each phase of the study.

Being tested
Standard (blonde) orange juice, Blood orange juice
Keywords
Cardiovascular disease, blood orange juice, anthocyanins
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard (blonde) orange juiceOther

    Consumption of 500ml standard (blonde) orange juice daily for 28 days

  • Blood orange juiceOther

    Consumption of 500ml blood orange juice daily for 28 days

Study groups in NCT02195934
Study groupRoleWhat they receive
Standard orange juice (OJ) followed by blood OJOtherThis randomized 2-way cross over study will compare the effect of blood orange juice with that of a standard (blonde) orange juice consumed daily for 28 days, on markers of cardiovascular disease, with a 3 week washout period in between.
Receives: Other: Standard (blonde) orange juice; Other: Blood orange juice
Blood orange juice followed by standard OJOtherThis randomized 2-way cross over study will compare the effect of blood orange juice with that of a standard (blonde) orange juice consumed daily for 28 days, on markers of cardiovascular disease, with a 3 week washout period in between.
Receives: Other: Standard (blonde) orange juice; Other: Blood orange juice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LDL cholesterol

    The primary outcome measure will be the change in concentration of LDL cholesterol as a result of the daily consumption of standard (blonde) orange juice or blood orange juice for 28 days (4 weeks).

    Measured: 28 days (4 weeks)

Secondary outcomes (1)

  1. CVD biomarkers

    The secondary outcome measure include measuring the change in concentration of levels of other markers of CVD, HDL, total cholesterol, nitrites, nitrates, nitrosols, interleukin 6, high sensitivity C reactive protein, Dglucose, insulin and endothelin 1 as a result of daily consumption of standard (blonde) orange juice or blood orange juice for 28 days (4 weeks).

    Measured: 28 days (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195934
Sponsor's protocol ID
IFR03/2014
Other IDs
14/EE/0219, 155431, 2014GP23
Acronym
OJ & CVD
Status last verified
Apr 2016
First submitted
18 Jul 2014
Last updated
5 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • Hollands WJ, Armah CN, Doleman JF, Perez-Moral N, Winterbone MS, Kroon PA. 4-Week consumption of anthocyanin-rich blood orange juice does not affect LDL-cholesterol or other biomarkers of CVD risk and glycaemia compared with standard orange juice: a randomised controlled trial. Br J Nutr. 2018 Feb;119(4):415-421. doi: 10.1017/S0007114517003865.

    PubMed 29498348

Questions about this trial

What is this clinical trial studying?

A study testing Standard (blonde) orange juice and Blood orange juice in people with Cardiovascular Disease, run by Quadram Institute Bioscience at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL cholesterol (time frame: 28 days (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195934, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016; AzTrials last refreshed its copy on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in