Plain English Summary
Background and study aims
Successful treatment for HIV has lead to an ageing HIV-positive population with heart disease as the most common cause of death. The underlying cause of the increased risk of heart disease observed in HIV is not understood, and cannot be explained by traditional risk factors. Lifestyle intervention is recommended, with a low-fat diet to promote cholesterol reduction. The addition of functional foods (such as plant stanols and nuts) produces more dramatic reductions in cholesterol. This is based on evidence from the general population. This study will find out if the Ultimate Cholesterol Lowering Plan (UCLP) will have a similar effect in people who have raised cholesterol due to their HIV infection and treatment.
Who can participate?
Adults with HIV infection on stable antiretroviral therapy and raised cholesterol can take part in this study.
What does the study involve?
Participants will be randomly allocated to receive dietary advice on either reducing saturated fat alone, or together with increasing intake of nuts, plant stanols, soya protein, olive oil, beans and oats (components of the UCLP), delivered for 6 months. Results from blood tests, questionnaires and interviews will assess the impact of the UCLP on the risk of heart disease in adults with HIV infection on antiretroviral therapy.
What are the possible benefits and risks of participating?
If this diet can significantly reduce blood cholesterol levels, patients may reduce their risk of a heart attack. Risks to participants are not expected in this study. Potential malabsorption of fat soluble vitamins will be monitored. Participants will be directed to their doctor in the case of any health concerns arising during the study.
Where is the study run from?
The study is run from the Heart of England NHS Foundation Trust (UK), University Hospital Birmingham (UK) and Coventry and Warwickshire Partnership NHS Trust (UK).
When is the study starting and how long is it expected to run for?
The study starts in September 2013 and is expected to run until September 2016.
Who is funding the study?
National Institute for Health research (NIHR) (UK)
Who is the main contact?
Mrs Clare Stradling
clare.stradling@heartofengland.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Clare Stradling
ORCID ID
Contact details
Birmingham Heartlands Hospital
3 Bordesley Green East
Bordesley Green
Birmingham
B9 5SS
United Kingdom
-
clare.stradling@heartofengland.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14823
Study information
Scientific title
A randomised controlled pilot study to assess the feasibility of the ultimate cholesterol lowering plan dietary intervention for cardiovascular risk reduction in HIV dyslipidaemia
Acronym
BFF Trial
Study hypothesis
To test the feasibility and acceptability of the ultimate cholesterol lowering plan (UCLP).
Ethics approval
West Midlands - Solihull Research Ethics Committee, 24/06/2013, ref: 13/WM/0225
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology
Intervention
Dietary intervention:
Diet 1: low saturated fat
Diet 2: low saturated fat, Ultimate Cholesterol Lowering Plan within Mediterranean style diet
The intervention is for 6 months, the follow up is for 12 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
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
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
Overall trial start date
02/09/2013
Overall trial end date
02/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Participant 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
Recruitment start date
02/09/2013
Recruitment end date
02/09/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Heartlands Hospital
Birmingham
B9 5SS
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Doctoral Research Fellowship, UK; Grant Codes: NIHR-DRF-2012-05-204
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
08/06/2018: Results presented at Conference on Retroviruses and Opportunistic Infections (CROI) 2018: http://www.croiconference.org/sessions/mediterranean-portfolio-diet-hiv-dyslipidaemia-randomized-controlled-trial
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26857107