Condition category
Infections and Infestations
Date applied
04/04/2011
Date assigned
19/05/2011
Last edited
20/05/2011
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

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

Publication citations

Additional files

Editorial Notes