Compliance to six weeks supplementation of a nutritional concept constituted as a powder in HIV-1 positive adults not on Highly Active Anti-Retroviral Therapy (HAART)

Completed

Conditions: Human immunodeficiency virus (HIV)-1
Infections and Infestations
Human immunodeficiency virus [HIV] disease

Registration Number: ISRCTN03460688

Lead Sponsor: Danone Research (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. Human immunodeficiency virus (HIV)-1 positive adults who have not received HAART in the past year and are not anticipated to start HAART during the study period
2. Age 18 years and older
3. Males and non-pregnant, non-lactating females
4. CD4+ T-cell count 350 cells/µL or higher
5. Written informed consent

Exclusion Criteria

1. Lactose intolerance (not using a stable dose of lactase) or known allergy for any of the ingredients
2. Unable to adhere to protocol instructions (including illiterate persons)
3. Known inflammatory bowel diseases, coeliac disease
4. Investigators' uncertainty about the willingness or ability of the subject to comply with the protocol requirements [including intravenous (IV) drug users]
5. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Compliance to intake of a powder <br>1.1. Total number of study product consumed in 6 weeks<br>1.2. Average daily intake of study product<br>1.3. Average weekly intake of study product<br>1.4. Period of intake of study product<br>1.5. Change in intake of study product during the study)

Secondary Outcome Measures

Name	Time	Method
The effect of intake of the powder on:<br>1. Gastrointestinal tolerance (assessed at baseline, week 3 and week 6) <br>2. Gut health parameters (assessed at baseline and week 6) <br>3. Appreciation of the nutritional powder (assessed after first consumption, week 1, week 3 and week 6)<br><br>Compare compliance to intake of the powder with compliance to intake of the nutritional bar analysed in the ComBaT study