Best Foods For your heart trial: dietary intervention to reduce cardiovascular risk in HIV dyslipidaemia
| ISRCTN | ISRCTN32090191 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32090191 |
| Secondary identifying numbers | 14823 |
- Submission date
- 08/08/2013
- Registration date
- 08/08/2013
- Last edited
- 14/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Birmingham Heartlands Hospital
3 Bordesley Green East
Bordesley Green
Birmingham
B9 5SS
United Kingdom
| clare.stradling@heartofengland.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | BFF Trial |
| Study objectives | To test the feasibility and acceptability of the ultimate cholesterol lowering plan (UCLP). |
| Ethics approval(s) | West Midlands - Solihull Research Ethics Committee, 24/06/2013, ref: 13/WM/0225 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 02/09/2013 |
| Completion date | 02/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Total final enrolment | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/09/2013 |
| Date of final enrolment | 02/09/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
B9 5SS
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/02/2016 | Yes | No | |
| Results article | results | 01/03/2021 | 14/10/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/10/2020: Publication reference and total final enrolment number added.
28/05/2019: Internal review.
08/06/2018: The following changes were made to the trial record:
1. The public title was changed from 'Which Healthy Heart Diet for people living with HIV?' to 'Best Foods For your heart trial: dietary intervention to reduce cardiovascular risk in HIV dyslipidaemia'.
2. The acronym was changed from HHD Trial to BFF Trial.
3. Publication reference added.
