ISRCTN32090191已完成未知
A randomised controlled pilot study to assess the feasibility of the ultimate cholesterol lowering plan dietary intervention for cardiovascular risk reduction in HIV dyslipidaemia
niversity of Birmingham (UK)0 个研究点目标入组 60 人开始时间: 2013年8月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2016 protocol in https://www.ncbi.nlm.nih.gov/pubmed/26857107 2020 results in https://pubmed.ncbi.nlm.nih.gov/33032837/ (added 14/10/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years of age with stable HIV infection
- •2. On antiretroviral therapy for more than 6 months
- •3. Low Density Lipoprotein (LDL)-cholesterol >3mmol/l
- •4. Willing to make dietary changes
- •5. Able to give informed consent
- •Target Gender: Male & Female; Lower Age Limit 18 years
排除标准
- •1. Current opportunistic infection or recent weight loss in last 3 months
- •2. Pregnancy, or planning pregnancy in the next 6 months
- •3. Diagnosis of familial hyperlipidaemia (LDL-cholesterol >6mmol/l and family history)
- •4. Secondary causes of hypercholesterolemia
- •5. Renal or liver disease, diabetes, hypothyroidism (unless treated and on a stable dose of L-thyroxine)
- •6. Gross xanthoma, as this may predispose to hyper-absorption of plant sterols
- •7. Blood triglyceride level >10mmol/l, as this constitutes risk of pancreatitis
- •8. Nut allergy
- •9. Current use of lipid lowering agents, or any other interfering drug/diet
- •10. Cannot read and write in English, or inability to understand the printed materials
- •11. Any unstable psychiatric disorder, including known eating disorders
- •12. Current participation in a weight loss programme or other dietary intervention
研究者
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