Effect of conjugated linoleic acid on body fat in men with HIV receiving antiretroviral therapy
| ISRCTN | ISRCTN31131566 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31131566 |
| Secondary identifying numbers | RJ113/N295 |
- 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
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 12/02/2013 |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Harrison Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Sponsor information
University/education
Room 1.8 Hodgkin Building
Guy's Campus
King's College London
London
SE1 4UL
England
United Kingdom
| Website | http://www.kcl.ac.uk/index.aspx |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Hospital/treatment centre
16th Floor
Tower Wing
Guy’s Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Collegium Regale Londiniense, King's, KCL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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. 2015 results in thesis https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.677153 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
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.
