Effect of nutritional intervention with ready to use therapeutic food (RUTF) on blood lipid profiles of moderate to severely malnourished adults receiving antiretroviral therapy (ART)

A randomised controlled study assessing the effect of nutritional intervention with ready to use therapeutic food (RUTF) on blood lipid profiles of moderate to severely malnourished adults receiving antiretroviral therapy (ART) in Lusaka, Zambia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN04084517

Enrollment

168

Registered

2009-03-24

Start date

2009-01-26

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

HIV and malnutrition Infections and Infestations Human immunodeficiency virus [HIV] disease resulting in other specified diseases

Interventions

Participants will be randomly allocated to the following two arms: Intervention group: Participants will receive 2 jars/day of RUTF for 3 months, each jar weighs 250g (for 100g RUTF: energy content

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Eligible for ART or has started ART within last 2 weeks 2. Both males and females, age >=18 years to 50 6. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Pre-existing diabetes 2. History of cardiovascular disease (CVD) including hypercholestrolaemia, hypertension 3. On other medications that may have an effect on blood lipid profiles (besides routine HIV prophylaxis and tuberculosis [TB] treatment) 4. CD4 count <50 5. Unable to tolerate solid foods 6. Failed appetite test 7. Subjects with pacemakers or any implantable electronic devices 8. Pregnancy or lactation 9. Psychiatric illness 10. Nut allergies 11. Consent declined 12. Any other reason why the consenting investigator thinks it is not appropriate for them to take part

Design outcomes

Primary

Measure	Time frame
Total cholesterol/high density lipoprotein cholesterol (TC/HDL-C) ratio (TC/HDL-c ratio >= 5), assessed at baseline, Month 3, 6, 9 and 12 after enrolment into the study.	—

Secondary

Measure	Time frame
The following will be assessed at baseline, Month 3, 6, 9 and 12 after enrolment into the study: 1. Lipid profile: 1.1. Mean change in total cholesterol (TC) 1.2. Mean change in high density lipoprotein cholesterol (HDL-c) 1.3. Mean change in low density lipoprotein cholesterol (LDL-c) 1.4. Mean change in total triglycerides (TG) 2. Body composition: The endpoints will be the correlation between change in TC and in: 2.1. Body fat mass proportion 2.2. Fat free mass (FFM) proportion 2.3. Fat-free mass index (FFMI) which controls for height 3. Nutritional status: The endpoints will be the correlation between change in TC and in: 3.1. Weight (kg) 3.2. MUAC (mm) 3.3. BMI (kg/m^2) 3.4. Waist circumference Note: Some of the secondary endpoints (e.g., weight, MUAC, waist measurements) may be taken at two weekly intervals from baseline up to Month 3 as well as at the timepoints indicated above.	—

Measure

Time frame

The following will be assessed at baseline, Month 3, 6, 9 and 12 after enrolment into the study: 1. Lipid profile: 1.1. Mean change in total cholesterol (TC) 1.2. Mean change in high density lipoprotein cholesterol (HDL-c) 1.3. Mean change in low density lipoprotein cholesterol (LDL-c) 1.4. Mean change in total triglycerides (TG) 2. Body composition: The endpoints will be the correlation between change in TC and in: 2.1. Body fat mass proportion 2.2. Fat free mass (FFM) proportion 2.3. Fat-free mass index (FFMI) which controls for height 3. Nutritional status: The endpoints will be the correlation between change in TC and in: 3.1. Weight (kg) 3.2. MUAC (mm) 3.3. BMI (kg/m^2) 3.4. Waist circumference Note: Some of the secondary endpoints (e.g., weight, MUAC, waist measurements) may be taken at two weekly intervals from baseline up to Month 3 as well as at the timepoints indicated above.

—

Countries

Zambia

Outcome results

None listed

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