Condition category
Infections and Infestations
Date applied
08/08/2013
Date assigned
08/08/2013
Last edited
12/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

HHD Trial

Study hypothesis

To test the feasibility and acceptability of the ultimate cholesterol lowering plan (UCLP).

Ethics approval

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 below 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes