ISRCTN86702316已完成未知
The Orange Juice and Cardiovascular Disease Study: a randomised controlled trial
Institute of Food Research (UK)0 个研究点目标入组 42 人开始时间: 2014年7月25日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29498348 (added 10/06/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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