Effect of conjugated linoleic acid on body fat in men with HIV receiving antiretroviral therapy

• Register: ISRCTN
• Last refreshed on: 19 October 2020
• Main ID: ISRCTN31131566
• Date of registration: 10/03/2015
• Prospective Registration: No
• Primary sponsor: King's College London
• Public title: Effect of conjugated linoleic acid on body fat in men with HIV receiving antiretroviral therapy
• 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
• Date of first enrolment: 17/01/2014
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN31131566
• Study type: Interventional
• Study design: Double-blind randomised placebo-controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Anne Mullen

• Name: Cathriona Loonam

Key inclusion & exclusion criteria

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)

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


Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

HIV-associated lipodystrophy
Nutritional, Metabolic, Endocrine
HIV-associated lipodystrophy

Intervention(s)

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

Primary Outcome(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

Secondary Outcome(s)

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)

Secondary ID(s)

RJ113/N295

Source(s) of Monetary Support

King’s College London

Secondary Sponsor(s)

Guy’s and St Thomas’ NHS Foundation Trust

Ethics review

Status:
Approval date:
Contact:

Queen Square Ethics Committee (UK), 12/09/2013, ref: 13/LO/1145

Results

• Results available: Yes
• Date Completed: 30/04/2014