Topic: Infection
Conditions
Interventions
Dietary intervention:
Diet 1: low saturated fat
Diet 2: low saturated fat, Ultimate Cholesterol Lowering Plan within Mediterranean style diet
The interv
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Difference in LDL-cholesterol between groups at 6 months 2. Estimates of variability and effect size for waist circumference, arterial stiffness, and other cardiovascular risk factors | — |
Countries
United Kingdom
Outcome results
None listed