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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31131566

Enrollment

Registered

2015-03-10

Start date

2014-01-17

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

United Kingdom

Contacts

Public ContactCathriona Loonam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026