Human immunodeficiency virus (HIV-1) Infections and Infestations Human immunodeficiency virus (HIV-1)
Conditions
Interventions
1. Duration of intervention: 6 weeks
2. Week 1: One nutritional bar of 40 grams daily
3. Week 2-6: One nutritional bar of 40 grams twice daily
Sponsors
Danone Research (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HAART - naïve adults with confirmed HIV-1 infection 2. Age 18 years and older 3. Males 4. Non-pregnant, non-lactating females 5. CD4+ T-cell counts 400 cells/µL or higher at screening 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Lactose intolerance or known allergy for any of the ingredients 2. Unable to adhere to protocol instructions (including illiterate persons) 3. Known inflammatory bowel diseases 4. Coeliac disease 5. Investigators' uncertainty about the willingness or ability of the subject to comply with the protocol requirements (IV drug users are considered as probably non-compliant) 6. Anticipated to start HAART during the study period 7. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study and during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Compliance to intake of a nutritional bar 2. Total number of bars consumed in 6 weeks 3. Average daily intake of bars 4. Average weekly intake of bars 5. Period of intake of bars | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of intake of the nutritional bar on: 1. Gastrointestinal tolerance (assessed at baseline, week 3 and week 6) 2. Gut health parameters (assessed at baseline and week 6) 3. Activation markers in blood (assessed at baseline and week 6) 4. Appreciation of the nutritional bar (assessed after first consumption, week 1, week 3 and week 6) | — |
Countries
Netherlands
Outcome results
None listed