Compliance to supplementation of a nutritional Bar for six weeks in Highly Active AntiRetroviral Therapy (HAART) - naïve HIV-1 positive adults
| ISRCTN | ISRCTN76848857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76848857 |
| Secondary identifying numbers | 100158 |
- Submission date
- 04/04/2011
- Registration date
- 19/05/2011
- Last edited
- 19/05/2011
- 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 | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Compliance to supplementation of a nutritional bar for six weeks in Highly Active AntiRetroviral Therapy (HAART) - naïve HIV-1 positive adults |
| Study acronym | ComBaT |
| Study objectives | Exploratory study to assess whether the product format (nutritional bar) is suitable for longer term use in the target population |
| Ethics approval(s) | Independent Review Board Nijmegen, The Netherlands, 9 May 2006, ref: TC2006004F-HDJ |
| Health condition(s) or problem(s) studied | Human immunodeficiency virus (HIV-1) |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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) |
| Overall study start date | 20/06/2006 |
| Completion date | 22/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 planned, 27 actual |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/06/2006 |
| Date of final enrolment | 22/08/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Bosrandweg 20
Wageningen
6704 PH
Netherlands
6704 PH
Netherlands
Sponsor information
Danone Research (Netherlands)
Industry
Industry
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands
| Phone | +31 317 467 800 |
|---|---|
| barbara.mourmans@danone.com | |
| Website | http://www.research.danone.com/means_to_succeed/the_research_center/netherlands |
"ROR" |
https://ror.org/01c5aqt35 |
Funders
Funder type
Industry
Danone Research B.V. (The 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 |
