A randomised, double-blind, controlled study on the effect of one year administration of a nutritional concept on immunological status in human immunodeficiency virus-1 positive adults not on anti-retroviral therapy

ISRCTN	ISRCTN81868024
DOI	https://doi.org/10.1186/ISRCTN81868024
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Remko Hiemstra
Scientific

Numico Research B.V.
PO Box 7005
Wageningen
6700 CA
Netherlands

Phone	+31 (0)317 467 991
Email	Remko.Hiemstra@numico-research.nl

Study design	Randomised, placebo controlled, parallel group, double blinded, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	BITE (Blinded nutritional study for Immunity and Tolerance Evaluation)
Study objectives	Improving the immunological status of Human Immunodeficiency Virus-1 (HIV-1) infected adults not on antiretroviral therapy through nutritional support.
Ethics approval(s)	Approval received from the Medisch Ethische Commissie AMC on the 20th September 2006 (ref: Internal Numico: 100157; Ethics board: MEC 06/199).
Health condition(s) or problem(s) studied	HIV
Intervention	Intervention group: A nutritional concept containing specific selected ingredients. Control group: Isocaloric nutritional product with an almost identical appearance and flavour as the investigational product though without the specific selected ingredients. Patients will be supplied with either a nutritional test or a control product for a period of 12 months.
Intervention type	Other
Primary outcome measure	Change from baseline in CD4+ T-cell count during 12 months.
Secondary outcome measures	Changes from baseline during one year in: 1. Immune markers other than CD4+ T-cell count 2. Viral load (HIV-1 RNA)
Overall study start date	23/01/2007
Completion date	30/04/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	800
Key inclusion criteria	Main inclusion criteria: 1. HIV-1 positive adults who have not received (Highly Active) Anti-Retroviral Therapy ([HA]ART) in the past year and are not anticipated to start therapy within the next six months 2. HIV-1 Ribonucleic Acid (RNA) more than 5,000 copies/ml in the three months prior to screening visit 3. CD4+ T-cell count less than or equal to 800 cells/µl in the three months prior to screening visit 4. More than or equal to 18 years old
Key exclusion criteria	Main exclusion criteria: 1. (HA)ART anticipated to be required within the next six months 2. Unintended weight loss of more than 10% in the three months prior to screening visit
Date of first enrolment	23/01/2007
Date of final enrolment	30/04/2009

Numico Research B.V.

Wageningen
6700 CA
Netherlands

Numico Research B.V. (The Netherlands)
Industry

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Website	http://www.numico.com/en/
"ROR"	https://ror.org/00aj77a24

Industry

Numico Research B.V. (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013		Yes	No