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)

Completed

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

Registration Number: ISRCTN04084517

Lead Sponsor: Valid International (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 168

Inclusion Criteria

1. Eligible for ART or has started ART within last 2 weeks
2. Both males and females, age >=18 years to <=49 years
3. mid-upper arm circumference (MUAC) <22.0 cm
4. Body mass index (BMI) <17.0 kg/m^2
5. CD4 Count >50
6. Signed informed consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The following will be assessed at baseline, Month 3, 6, 9 and 12 after enrolment into the study: <br><br>1. Lipid profile: <br>1.1. Mean change in total cholesterol (TC) <br>1.2. Mean change in high density lipoprotein cholesterol (HDL-c) <br>1.3. Mean change in low density lipoprotein cholesterol (LDL-c) <br>1.4. Mean change in total triglycerides (TG) <br><br>2. Body composition: <br>The endpoints will be the correlation between change in TC and in: <br>2.1. Body fat mass proportion <br>2.2. Fat free mass (FFM) proportion <br>2.3. Fat-free mass index (FFMI) which controls for height <br><br>3. Nutritional status: <br>The endpoints will be the correlation between change in TC and in: <br>3.1. Weight (kg) <br>3.2. MUAC (mm) <br>3.3. BMI (kg/m^2) <br>3.4. Waist circumference <br><br>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.