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Clinical Trials/ISRCTN32090191
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

Registry
who.int
Start Date
August 8, 2013
End Date
September 2, 2016
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Birmingham (UK)

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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