Effect of conjugated linoleic acid on body fat in men with HIV receiving antiretroviral therapy
| ISRCTN | ISRCTN31131566 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31131566 |
| Protocol serial number | RJ113/N295 |
| Sponsors | King's College London, Guy’s and St Thomas’ NHS Foundation Trust |
| Funder | King’s College London |
- Submission date
- 26/01/2015
- Registration date
- 10/03/2015
- Last edited
- 05/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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 research has shown that CLA is able to increase fat storage and improve fat cell function. The aim of 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 are randomly allocated to one of two groups to take either CLA or placebo (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?
January 2014 to April 2014
Who is funding the study?
King's College London (UK)
Who is the main contact?
Dr Cathriona Loonam
Contact information
Public
Room 4.46
Franklin Wilkins Building
King's College London
150 Stamford Street
London
SE1 9NH
United Kingdom
Scientific
6th Floor
210 High Holborn
London
WC1V 7EP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | CLAART |
| Study objectives | Conjugated linoleic acid (CLA) will reduce waist circumference in HIV-infected men receiving highly active antiretrovial therapy (HAART). |
| Ethics approval(s) | Queen Square Ethics Committee (UK), 12/09/2013, ref: 13/LO/1145 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Measured at baseline, week 6 and week 12: |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 60 |
| Total final enrolment | 5 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 17/01/2014 |
| Date of final enrolment | 30/04/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Harrison Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/10/2020: The following changes have been made:
1. A thesis link has been added to the publication and dissemination plan. No journal publications are expected.
2. The final enrolment number has been added from the thesis.
10/07/2017: No publications found, verifying study status with principal investigator.
