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)

ISRCTN	ISRCTN04084517
DOI	https://doi.org/10.1186/ISRCTN04084517
Protocol serial number	N/A
Sponsor	Valid International (UK)
Funder	Valid international (UK)

Submission date: 20/01/2009
Registration date: 24/03/2009
Last edited: 24/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sandra Mutuma
Scientific

Valid International/ Nutrition
Addis Abba Road/ Chaholi Road
Alex Masala Close
Plot 4126
Lusaka
P.O. Box 50719
Zambia

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study acronym	LRS (Lipid Research Study)
Study objectives	The use of high fat energy dense ready to use therapeutic food in HIV positive malnourished adults receiving antiretroviral therapy (ART) does not produce deleterious changes in their blood lipid profiles.
Ethics approval(s)	University of Zambia Biomedical Research Ethics Committee, approved on 20/11/2008 (ref: 009-10-08)
Health condition(s) or problem(s) studied	HIV and malnutrition
Intervention	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 = 530 kcal, of which 47-59% are from oil and 10% are protein calories) in addition to prescribed ART regimen, nutritional advice and counselling. Control group: Participants will receive ART, nutritional advice and counselling only Total duration of interventions: 3 months This trial will initially be a single-centre trial but may be extended to be a two-centre trial depending on recruitment rates.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	168
Key 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
Key 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
Date of first enrolment	26/01/2009
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

Zambia

Study participating centre

Valid International/ Nutrition

Lusaka
P.O. Box 50719
Zambia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes