Condition category
Infections and Infestations
Date applied
04/04/2011
Date assigned
19/05/2011
Last edited
19/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Barbara Mourmans

ORCID ID

Contact details

Bosrandweg 20
Wageningen
6704 PH
Netherlands

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

Publication citations

Additional files

Editorial Notes