Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
HIV infection can make it difficult for the body to absorb nutrients properly and the diet of a HIV patient with poor access to food will often be grossly inadequate. It is likely that the weight loss during disease is largely due to loss of lean body mass (muscle and organ tissues), but weight gain during recovery and after initiation of medical HIV treatment (ART) is mainly due to accumulation of fat. This is likely to have a negative impact on the health and survival of the HIV infected patient, particularly when quality of the diet is poor. It is possible that milk components as part of nutritional support could improve weight gain, growth, and recovery from malnutrition, but this needs to be confirmed. However, it is not clear whether nutritional support would work best and be safest when given from the beginning of ART, or whether it should be delayed until the acute stage of the infection and the side effects accompanying initiation of ART (such as anorexia and reduced absorption of nutrients) have declined. The aim of this study is to look at the effect of a whey-containing nutritional supplement on adult HIV patients starting ART in Jimma, Ethiopia. The protein source in the supplement will be either whey or soy. All participants will receive a peanut-based food supplement covering half of their daily energy need for three months. Since the optimal timing of nutritional support is unknown, patients who are not severely malnourished will receive the supplement either in the first three or the subsequent three months on ART.

Who can participate?
The study will be conducted among 350 HIV patients. Adults (≥18 years) initiating ART can participate in the study. Severely wasted individuals (body mass index<16 kg/m2) are excluded and referred for routine treatment for severe acute malnutrition at the hospital.

What does the study involve?
Patients are invited to take a peanut butter-based nutrient supplement daily for three months either during the first three or the subsequent three months upon initiation of ART. The supplement will have either whey or soy as the main protein source. Participants will be randomly selected to receive their 3 month supply of supplement either immediately, or after a three month delay. Each participant will be examined monthly during the first 6 months, followed by a final examination 12 months after starting ART. The supplement is distributed from the research clinic at each monthly visit. Quality of life will be assessed and compared between the treatment groups using a questionnaire tool developed by the World Health Organisation (WHO) adapted to local context. Body composition will be assessed at the beginning of the trial and after 3 and 6 months. Grip strength will be measured, and physical activity will be assessed using the ActiHeart, a small combined accelerometer and heart rate monitor. Finally, blood samples will be taken from participants.

What are the possible benefits and risks of participating?
All patients will benefit from three months of daily supplementation with a high energy dietary supplement with high quality proteins of different origin. There are no known risks of the supplement. As the patients have HIV, they are already at high risk of disease and death, but the supplements are not expected to increase these risks.

Where is the study run from?
Jimma University Hospital, Ethiopia.

When is the study starting and how long is it expected to run for?
Recruitment began in July 2010 and ended in August 2012. Each participant is in the study for 12 months. The last 12-month follow-up visit will be conducted in August 2013.

Who is funding the study?
US Dairy export council (USDEC) and Danish International Development Agency (DANIDA)

Who is the main contact?
Dr Pernille Kæstel

Trial website

Contact information



Primary contact

Prof Kim Fleischer Michaelsen


Contact details

University of Copenhagen
Department of Human Nutrition
Rolighedsvej 30
Frederiksberg C

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The role of nutritional support of human immunodeficiency virus (HIV) infected patients on antiretroviral treatment: a randomised trial in Jimma, Ethiopia



Study hypothesis

Ready-to-use supplementary foods (RUSF) given to human immunodeficiency virus (HIV) patients during the first three months of antiretroviral therapy (ART) increases lean body mass and physical performance, and the effect is larger if the supplement contains whey protein rather than soy.

On 10/01/2013 the following changes were made to the record:
1. The target number of participants was updated from 400 to 350.
2. The overall trial end date was updated from 31/12/2011 to 30/08/2013.

Ethics approval

1. Ethiopia: National Health Research Ethics Review Committee, 09/12/2009, ref: RDHE/30-90/2009
2. Denmark: Danish National Committee on Biomedical Research Ethics, 16/01/2009, ref: 2008-7041-137/sumih

Study design

Randomised single-blind nutritional supplementation trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Human immunodeficiency virus (HIV) infection


200 g per day of a RUSF containing whey or soy protein for three months from the start of ART, or no supplement for the first three months, but the same supplement from three to six months after the start of ART.

Total duration of treatment: 3 months
Total duration of follow-up: 12 months

Intervention type



Drug names

Primary outcome measures

Change over the first three months in:
1. Lean body mass as assessed using deuterium dilution test
2. Grip strength as assessed using a dynamometer
3. Physical activity assessed using a combined accelerometer and heart rate monitor

Secondary outcome measures

Measured after three months:
1. ART drug levels
2. HIV load and CD4 counts
3. Adherence to ART and quality of life
4. IGF-1

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. HIV-infected adults (aged greater than or equal to 18 years, either sex) commencing ART
2. Living within approximately 50 km from Jimma
3. Consenting to participate

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Pregnant or lactating
2. Terminally ill from HIV or other serious condition
3. Patients who may not be able to consume RUSF due to extensive oral lesion
4. Patients with nutritional oedema

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University of Copenhagen
Frederiksberg C

Sponsor information


University of Copenhagen (Denmark)

Sponsor details

Department of Human Nutrition
Rolighedsvej 30

Sponsor type




Funder type


Funder name

US Dairy Export Council (USDEC) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Danida (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in:
2014 results in:

Publication citations

  1. Results

    Olsen MF, Abdissa A, Kæstel P, Tesfaye M, Yilma D, Girma T, Wells JC, Ritz C, Mølgaard C, Michaelsen KF, Zerfu D, Brage S, Andersen AB, Friis H, Effects of nutritional supplementation for HIV patients starting antiretroviral treatment: randomised controlled trial in Ethiopia., BMJ, 2014, 348, g3187.

Additional files

Editorial Notes