ISRCTN32090191
Completed
N/A
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 sites60 target enrollmentAugust 8, 2013
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Topic: Infection
- Sponsor
- niversity of Birmingham (UK)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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