Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
100158
Study information
Scientific title
Compliance to supplementation of a nutritional bar for six weeks in Highly Active AntiRetroviral Therapy (HAART) - naïve HIV-1 positive adults
Acronym
ComBaT
Study hypothesis
Exploratory study to assess whether the product format (nutritional bar) is suitable for longer term use in the target population
Ethics approval
Independent Review Board Nijmegen, The Netherlands, 9 May 2006, ref: TC2006004F-HDJ
Study design
Open-label single-centre pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
20/06/2006
Overall trial end date
22/08/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 planned, 27 actual
Participant 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
Recruitment start date
20/06/2006
Recruitment end date
22/08/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Bosrandweg 20
Wageningen
6704 PH
Netherlands
Sponsor information
Organisation
Danone Research (Netherlands)
Sponsor details
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands
+31 317 467 800
barbara.mourmans@danone.com
Sponsor type
Industry
Website
http://www.research.danone.com/means_to_succeed/the_research_center/netherlands
Funders
Funder type
Industry
Funder name
Danone Research B.V. (The Netherlands) Centre for Specialised Nutrition
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary