Best Foods For your heart trial: dietary intervention to reduce cardiovascular risk in HIV dyslipidaemia

Not Applicable

Completed

• Conditions: Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations

• Registration Number: ISRCTN32090191
• Lead Sponsor: niversity of Birmingham (UK)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-08
• Study Completion: 2016-09-02
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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
11. Any unstable psychiatric disorder, including known eating disorders
12. Current participation in a weight loss programme or other dietary intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability of trial procedures for recruitment, allocation, retention and the intervention. They will be measured at baseline, 6 and 12 months. Method used to measure these outcomes: recruitment rate, attrition rate, process evaluation questionnaires and qualitative interviews, compliance rate of participation, adherence to dietary intervention using food diaries and 5 question compliance score.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Difference in LDL-cholesterol between groups at 6 months<br> 2. Estimates of variability and effect size for waist circumference, arterial stiffness, and other cardiovascular risk factors<br>