Plain English Summary
Background and study aims
The use of HAART in human immunodeficiency virus (HIV) management may lead to the development of HIV-associated lipodystrophy syndrome (HALS), characterised by abnormal body fat distribution (fat gain on the abdomen and fat loss from the face, arms and legs), high plasma triglycerides, high blood pressure and blood vessel dysfunction. HALS increases the risk of premature heart disease. Up to 85% of patients with HALS report that body shape changes have been noticed by friends, family or work colleagues. HALS has been shown to adversely affect quality of life and may cause stigma, low self-esteem, anxiety and depression. CLA is a fatty acid found naturally in milk and dairy products. HALS has been suggested to occur as a result of antiretroviral drugs altering the ability of fat cells to store fat. When fat cells in the face, arms and legs no longer store fat correctly, this fat leaks from fat cells and is taken up by fat cells in the abdomen. Recent work by our group has shown that CLA is able to increase fat storage and improve fat cell function. The aim in this study is to investigate the effects of CLA on abdominal fat.
Who can participate?
Men with HIV who are receiving HAART and have a waist circumference greater than 94 cm (37 inches) or body-mass index greater than 25 kg/m2.
What does the study involve?
Participants will be randomly assigned to one of two groups: intervention (3 g CLA/day) or placebo (3 g high oleic sunflower oil) for 12 weeks.
What are the possible benefits and risks of participating?
A benefit is that the findings of this study will help identify whether CLA can reduce waist circumference and improve body fat abnormalities in men with HIV.
Where is the study run from?
St Thomas' Hospital (UK)
When is the study starting and how long is it expected to run for?
From January 2014 to April 2014
Who is funding the study?
King's College London (UK)
Who is the main contact?
Dr Cathriona Loonam
Trial website
Contact information
Type
Public
Primary contact
Dr Cathriona Loonam
ORCID ID
Contact details
Room 4.46
Franklin Wilkins Building
King's College London
150 Stamford Street
London
SE19NH
United Kingdom
Type
Scientific
Additional contact
Dr Anne Mullen
ORCID ID
Contact details
6th Floor
210 High Holborn
London
WC1V 7EP
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RJ113/N295
Study information
Scientific title
Effects of a novel dairy fat (Conjugated Linoleic Acid) on body fat in men with HIV receiving highly active Anti-Retroviral Therapy (CLAART): a randomised controlled study
Acronym
CLAART
Study hypothesis
Conjugated linoleic acid (CLA) will reduce waist circumference in HIV-infected men receiving highly active antiretrovial therapy (HAART)
Ethics approval
Queen Square Ethics Committee (UK), 12/09/2013, reference number 13/LO/1145
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
HIV-associated lipodystrophy
Intervention
1. Treatment arm: 3 g/day of mixed CLA isomers (cis9,trans11 and trans10,cis12; Clarinol A80)
2. Placebo: 3 g/day of high oleic sunflower oil
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Change in waist circumference: taken as the midpoint between the lowest rib and the right ilium at the mid-axillary line and measured at baseline, 6 weeks and 12 weeks
Secondary outcome measures
Measured at baseline, week 6 and week 12:
1. Body-mass index (weight and height measured using a Seca scale and stadiometer)
2. Body composition using Tanita bioelectrical impedance analyser (model TBF 300MA)
3. Body fat measured using skinfold caliper (Holtain)
4. 24-hour recall (using multiple pass 24-hour recall technique)
5. Liver function, plasma lipids and plasma glucose
Measured at week 6 and week 12 only:
1. Food frequency questionnaire (using the previously validated EPIC)
2. Physical activity questionnaire (using the the International Physical Activity Questionnaire - Short Form)
Measured at baseline and week 12 only:
1. Plasma CLA levels (measured using gas chromatography)
2. Oxidative stress (measured using a 2-thiobarbituric acid reactive substances assay)
3. Adipocytokines (measured using a cytokine and growth factor array cytokine chip array kit)
4. CD4 count (measured using flow cytometry)
5. HIV viral load determined by reverse-transcriptase polymerase chain reactoRT-PCR using the COBAS® AmpliPrep/COBAS® Taqman® HIV-1 Test v2.0 (Roche Diagnostics, Mannheim, Germany).
Overall trial start date
12/02/2013
Overall trial end date
30/04/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. HIV positive
2. Age 18–55 years
3. On HAART
4. Waist circumference greater than > 94 cm (37 inches) or ethnic-specific cutoff)
5. Overweight (body-mass index > 25kg/m2)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
60
Participant exclusion criteria
1. Current AIDS-defining illness
2. Any acute/chronic condition that might affect the interpretation of the results or the participant's ability to follow protocol correctly
3. Fasting hypertriglyceridaemia (> 1.7 mmol/L)
4. Fasting hyperglycaemia (> 7mmol/L)
5. Male subjects on testosterone replacement therapy
6. Use of any medication designed to reduce weight/body fat
7. Participants following a diet (self-prescibed or practitioner-prescribed) to reduce weight/body fat
8. Use of fat-based supplements (e.g., fish oils) in the previous 3 months
9. Known hypersensitivity to the investigational products according to the participant and medical notes
Recruitment start date
17/01/2014
Recruitment end date
30/04/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
Department of Infectious Diseases
Harrison Wing
Westminster Bridge Road
London
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
Room 1.8 Hodgkin Building
Guy's Campus
King's College London
London
SE1 4UL
United Kingdom
Sponsor type
University/education
Website
Organisation
Guy’s and St Thomas’ NHS Foundation Trust
Sponsor details
16th Floor
Tower Wing
Guy’s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
King's College London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Due to the small sample size, it was difficult to conduct any meaningful statistical analysis on data gathered as part of the study. Therefore, the data from this study will not be published.
Intention to publish date
Participant level data
Stored in repository
Results - basic reporting
Publication summary