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)

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): an open-label single-centre pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN03460688

Enrollment

Registered

2011-05-19

Start date

2006-10-16

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Duration of intervention: 6 weeks Week 1: One sachet containing 45 grams of powder daily Week 2-6: One sachet containing 45 grams of powder twice daily The powder had to be dissolved in at least 100 m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Compliance to intake of a powder 1.1. Total number of study product consumed in 6 weeks 1.2. Average daily intake of study product 1.3. Average weekly intake of study product 1.4. Period of intake of study product 1.5. Change in intake of study product during the study)	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026