Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
100172
Study information
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
Acronym
ComBaT II
Study hypothesis
Exploratory study to assess whether the product format (nutritional powder) is suitable for long term use in the target population
Ethics approval
Independent Review Board Nijmegen, the Netherlands approved on 25th September 2006
Study design
Open-label single-centre pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
16/10/2006
Overall trial end date
27/12/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 planned, 24 actual
Participant 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
Recruitment start date
16/10/2006
Recruitment end date
27/12/2006
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(0)31 746 7800
barbara.mourmans@danone.com
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Danone Research B.V. (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