Status:
COMPLETED
The Orange Juice and Cardiovascular Disease Study
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
European Commission
Biotechnology and Biological Sciences Research Council
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
25-84 years
Phase:
NA
Brief 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 betw...
Eligibility Criteria
Inclusion
- Men and women aged 25-84 years
- Waist measurement
- Caucasians: Men \> 102cm (40inches); Women \>88cm (34inches)
- Asians: Men\> 90cm (35inches); Women 80cm (31inches)
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02195934
Start Date
July 1 2014
End Date
August 1 2016
Last Update
September 5 2016
Active Locations (1)
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1
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA