The Orange Juice and Cardiovascular Disease Study
| ISRCTN | ISRCTN86702316 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86702316 |
| ClinicalTrials.gov number | NCT02195934 |
| Secondary identifying numbers | 16925 |
- Submission date
- 25/07/2014
- Registration date
- 25/07/2014
- Last edited
- 10/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Anthocyanins are naturally occurring substances found in a variety of foods and drinks. They are responsible for the deep red, blue, purple and black colours of foods such as berry fruits, blood oranges and aubergine skins. Evidence suggests that anthocyanins may play a role in preventing diseases such as cardiovascular (heart) disease. The aim of this study is to look at the effects of drinking blood orange juice (with anthocyanins) and a standard blonde orange juice (without anthocyanins) on a variety of markers for cardiovascular disease risk.
Who can participate?
Healthy volunteers aged between 25 and 84 with a waist size of 40 inches or greater (men) or 34 inches or greater (women)
What does the study involve?
Participants are randomly allocated to drink up to 500mL of either blood or blond orange juice each day for 28 days, then after a 3-week break they drink the other juice for 28 days. Blood samples are collected at the start and end of each 28-day period for the measurement of markers of cardiovascular disease risk. Participants are expected to consume a diet low in anthocyanins from two weeks before starting the study and continuing throughout the study period (about 12 weeks in total).
What are the possible benefits and risks of participating?
There are no direct benefits of taking part in this study. However, the information obtained contributes to the evidence of the effects of anthocyanins on cardiovascular disease risk. Since this study involves blood sampling there can be a small amount of discomfort associated with taking blood. There is a risk that participants may develop a small bruise at the site of the blood sample but this fades as with any bruise.
Where is the study run from?
Institute of Food Research (UK)
When is the study starting and how long is it expected to run for?
August 2014 to December 2017
Who is funding the study?
European Commission (Belgium)
Who is the main contact?
Dr Charlotte Armah
charlotte.armah@ifr.ac.uk
Contact information
Scientific
Institute of Food Research
Norwich Research Park
Colney Lane
Colney
NR4 7UA
United Kingdom
| charlotte.armah@ifr.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The Orange Juice and Cardiovascular Disease Study: a randomised controlled trial |
| Study acronym | The OJ & CVD Study |
| Study objectives | This study aims to compare the effect of anthocyanin-rich blood orange juice with a standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease. |
| Ethics approval(s) | First MREC approval date 24/06/2014, ref: 14/EE/0219 |
| Health condition(s) or problem(s) studied | Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | Participants aged between 25 and 84 years of age will be recruited based on their waist measurement, with 42 participants required to complete the study. They will be required to consume up to 500mL of either blood or blond juice each day for 28 days in a two-way cross-over study. Prior to each part of the intervention there will be a 2 week run in period where participants will be asked to avoid consuming foods rich in anthocyanins. After the 28 day intervention period, there will be a 3 week wash out period after which the participant will be asked to then drink the other juice for 28 days. The 500 mL of blood orange juice will contain approximately 50mg of anthocyanins, whereas the standard juice will contain 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. This study is part of the EU funded FP7 ATHENA project. Follow Up Length: 0 month(s); Study Entry : Registration only |
| Intervention type | Other |
| Primary outcome measure | LDL-cholesterol, measured at baseline and 28 days after ingestion of standard blonde orange juice and blood orange juice |
| Secondary outcome measures | 1. Gene expression 2. Markers of CVD (total cholesterol, HDL-cholesterol, nitric oxide, CRP, insulin, glucose, ET-1) Measured at baseline and 28 days after ingestion of standard blonde orange juice and blood orange juice. |
| Overall study start date | 01/08/2014 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 42; UK Sample Size: 42; Description: It is a cross over design and so all participants will have the 2case" and the "control". |
| Key inclusion criteria | 1. Men and women aged 25-84 years 2. Waist measurement 2.1. Caucasians: Men > 102 cm (40 inches); Women >88 cm (34 inches) 2.2. Asians: Men > 90 cm (35 inches); Women 80 cm (31 inches) |
| Key exclusion criteria | 1. Those unable to give written informed consent 2. Those unwilling to provide GP details 3. Regular prescribed medication that may affect study outcome. This will be assessed on an individual basis-not including statins 4. Over-the-counter (non-prescribed) medication that may affect the study data. This will be assessed on an individual basis. 5. Allergy to the test juice drink or the actual fruit itself 6. Chronic medical conditions requiring active treatment. This will be assessed on an individual basis 7. Those already consuming blood orange juice, unless they are willing to discontinue consumption for 2 weeks prior to starting the study. 8. Diagnosed diabetics; 9. Peri-menopausal women (defined as: when there is a permanent change in menstrual cycle) 10. Women on HRT for less than one year 11. On thyroxine for less than one year 12. Women who are pregnant, have been pregnant within the last 12 months or who are breastfeeding 13. Those taking aspirin (prescribed or self-prescribed) 14. All blood pressure medication 15. 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 16. 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 17. 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 advisor on an individual basis 18. Peripheral vascular disease including claudication 19. 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 20. Parallel participation in another research project which has involved dietary intervention and/or sampling of blood 21. Any person related to or living with any member of the study team 22. 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) 23. Those who have donated or intend to donate blood within 16 weeks of the first and last study samples 24. Gastrointestinal disease (excluding hiatus hernia) unless symptomatic or study intervention/procedure is contraindicated 25. Those undergoing any on-going clinical investigations with their GP or hospital clinic. 26. Those who have had throat surgery or neck injury 27. Those with internal medical devices Screening exclusion criteria: 1. Results of the eligibility screening that indicate or are judged by the HNU medical advisor 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. 2. BMI <19.5 3. Weight >180kg (28stones) 4. Fasting total cholesterol > 8.0mmol/L |
| Date of first enrolment | 01/08/2014 |
| Date of final enrolment | 01/05/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Colney Lane
Colney
NR4 7UA
United Kingdom
Sponsor information
Research organisation
Institute of Food Research, Norwich Research Park
Colney Lane
Colney
NR4 7UA
United Kingdom
"ROR" |
https://ror.org/04td3ys19 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact journal in 2018. |
| IPD sharing plan | The datasets generated as part of the current study will be available upon request from paul.kroon@ifr.ac.uk once the results have been published in a high-impact journal. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2018 | 10/06/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/06/2019: The following changes were made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
3. The clinicaltrials.gov number has been added.
17/01/2017: The overall trial end date was changed from 01/01/2016 to 31/12/2017.
