Condition category
Circulatory System
Date applied
25/07/2014
Date assigned
25/07/2014
Last edited
25/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Armah

ORCID ID

Contact details

Institute of Food Research
Norwich Research Park
Colney Lane
Colney
NR4 7UA
United Kingdom
charlotte.armah@ifr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16925

Study information

Scientific title

Acronym

The OJ & CVD Study

Study hypothesis

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. 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.

Ethics approval

14/EE/0219; First MREC approval date 24/06/2014

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases

Intervention

The Orange Juice and CVD Study, . 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 w; Follow Up Length: 0 month(s); Study Entry : Registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

LDL cholesterol; Timepoint(s): The primary outcome measure will be the change in concentration of LDL cholesterol as a result of th

Secondary outcome measures

1. Gene Expression; Timepoint(s): The assessment of the activity of genes (gene expression) as a result of the daily consumption of s
2. Markers of CVD; Timepoint(s): The secondary outcome measure include measuring the change in concentration of levels of other marke

Overall trial start date

01/08/2014

Overall trial end date

01/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

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".

Participant 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

Recruitment start date

01/08/2014

Recruitment end date

01/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Food Research, Norwich Research Park , Colney Lane
Colney
NR4 7UA
United Kingdom

Sponsor information

Organisation

Institute of Food Research (UK)

Sponsor details

Institute of Food Research
Norwich Research Park
Colney Lane
Colney
NR4 7UA
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

European Commission

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes