The Orange Juice and Cardiovascular Disease Study

Not Applicable

Completed

• Conditions: Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases; Circulatory System

• Registration Number: ISRCTN86702316
• Lead Sponsor: Institute of Food Research (UK)

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29498348 (added 10/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-25
• Study Completion: 2017-12-31
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DL-cholesterol, measured at baseline and 28 days after ingestion of standard blonde orange juice and blood orange juice

Secondary Outcome Measures

Name	Time	Method
<br> 1. Gene expression<br> 2. Markers of CVD (total cholesterol, HDL-cholesterol, nitric oxide, CRP, insulin, glucose, ET-1)<br><br> Measured at baseline and 28 days after ingestion of standard blonde orange juice and blood orange juice.<br>