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

Bosrandweg 20
Wageningen
6704 PH
Netherlands

Study information

Study designOpen-label single-centre pilot study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleCompliance to supplementation of a nutritional bar for six weeks in Highly Active AntiRetroviral Therapy (HAART) - naïve HIV-1 positive adults
Study acronymComBaT
Study objectivesExploratory 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) studiedHuman immunodeficiency virus (HIV-1)
Intervention1. 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 typeOther
Primary outcome measure1. 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 measuresThe 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 date20/06/2006
Completion date22/08/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30 planned, 27 actual
Key inclusion criteria1. 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 criteria1. 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 enrolment20/06/2006
Date of final enrolment22/08/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Bosrandweg 20
Wageningen
6704 PH
Netherlands

Sponsor information

Danone Research (Netherlands)
Industry

Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands

Phone +31 317 467 800
Email barbara.mourmans@danone.com
Website http://www.research.danone.com/means_to_succeed/the_research_center/netherlands
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan