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)
| ISRCTN | ISRCTN03460688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03460688 |
| Secondary identifying numbers | 100172 |
- Submission date
- 04/04/2011
- Registration date
- 19/05/2011
- Last edited
- 20/05/2011
- 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
Ms Barbara Mourmans
Scientific
Scientific
Bosrandweg 20
Wageningen
6704 PH
Netherlands
Study information
| Study design | Open-label single-centre pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | ComBaT II |
| Study objectives | Exploratory study to assess whether the product format (nutritional powder) is suitable for long term use in the target population |
| Ethics approval(s) | Independent Review Board Nijmegen, the Netherlands approved on 25th September 2006 |
| Health condition(s) or problem(s) studied | Human immunodeficiency virus (HIV)-1 |
| Intervention | 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 ml cold water or cold dairy products before consumption. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 16/10/2006 |
| Completion date | 27/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 planned, 24 actual |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/10/2006 |
| Date of final enrolment | 27/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Bosrandweg 20
Wageningen
6704 PH
Netherlands
6704 PH
Netherlands
Sponsor information
Danone Research (Netherlands)
Research organisation
Research organisation
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands
| Phone | +31(0)31 746 7800 |
|---|---|
| barbara.mourmans@danone.com | |
"ROR" |
https://ror.org/01c5aqt35 |
Funders
Funder type
Research organisation
Danone Research B.V. (Netherlands) Centre for Specialised Nutrition
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
