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
Protocol serial number	100158
Sponsor	Danone Research (Netherlands)
Funder	Danone Research B.V. (The Netherlands) Centre for Specialised Nutrition

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

Ms Barbara Mourmans
Scientific

Bosrandweg 20
Wageningen
6704 PH
Netherlands

Primary study design	Interventional
Study design	Open-label single-centre pilot study
Secondary study design	Non randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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)
Completion date	22/08/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	27
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

Bosrandweg 20

Wageningen
6704 PH
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes