Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/01/2015
Date assigned
10/03/2015
Last edited
10/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes