Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LONZ1000
Study information
Scientific title
Immunomodulatory effects of a proprietary Arabinogalactan extract: a randomised double-blind placebo controlled parallel group study
Acronym
Study hypothesis
The hypothesis of this study is that ingestion of larch arabinogalactan will enhance immune function by increasing the antibody response in healthy volunteers to the 23-valent pneumonia vaccine.
Ethics approval
IRB approval was obtained from the Copernicus Group (Cary, NC) on the 2nd September 2008 (ref: MED4-08-256)
Study design
Randomised double-blind placebo controlled parallel group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Immune response to the 23-valent pneumococcal vaccine
Intervention
This is a randomised double-blind placebo controlled parallel group study with 45 healthy adults who had not previously had the pneumonia vaccine. The study was conducted at a single site Medicus Research clinical Research Center, Northridge, CA, USA.
Resistaid™ is an arabinogalactan extracted from the bark of the Larch tree (Larix spp., mostly Larix occidentalis; Lonza, Inc., Allendale, NJ). The placebo was maltodextrin (Maltin M100). The test product and the placebo were administered by mixing the powders into a beverage of the subject's choice for a maximum period of 72 days. The subjects were advised to take their dosage (4.5 g) once a day in the morning with breakfast.
Intervention type
Drug
Phase
Not Specified
Drug names
Arabinogalactan extract (Resistaid™)
Primary outcome measures
Measurements of:
1. Plasma levels of pneumococcal IgG (subtypes 4, 6B, 9V, 14, 18C, 19F and 23F; enzyme-linked immunosorbent assay [ELISA])
2. Salivary IgA (ELISA)
3. Peripheral white blood cell counts (lymphocytes, neutrophils, etc.,)
4. Plasma complement (C3 and C4)
5. Cytokine levels (epithelial neutrophil-activating peptide [ENA]-78, eotaxin, granulocyte monocyte colony stimulating factor [GM-CSF], interferon-gamma [IFNg], interleukin [IL]-10, IL-12P40, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-8, monocyte chemotactic protein [MCP]-1, MCP-3, platelet-derived growth factor [PDGF]-BB, tumour necrosis factor [TNF]-alpha A and leptin)
All outcomes measured at baseline, day 30, day 51, and day 72.
Secondary outcome measures
Oxidative stress via F2 isoprostance in urine. All outcomes measured at baseline, day 30, day 51, and day 72.
Overall trial start date
01/08/2008
Overall trial end date
01/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 to 65 years, either sex
2. Had a Body Mass Index (BMI) greater than 18 kg/m^2 and less than 30 kg/m^2 at screening
3. Agreed to all study visits and visit procedures
4. Agreed to use appropriate forms of birth control if females of child bearing potential
5. Agreed not to initiate/change any exercise or diet programs during the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Previously had the pneumococcal vaccine
2. Had allergies to the test product
3. Had any major systemic, inflammatory or chronic disease
4. Had any active infection or infection in the past month requiring antibiotics or anti-viral medication
5. Used immunosuppressive drugs in the prior 5 years
6. Known alcohol or drug abuse
7. Were pregnant or lactating
8. Had any medical condition which in the opinion of the investigator might interfere with the subject's ability in the trial
Recruitment start date
01/08/2008
Recruitment end date
01/12/2008
Locations
Countries of recruitment
United States of America
Trial participating centre
18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America
Sponsor information
Organisation
Lonza, Inc (USA)
Sponsor details
90 Boroline Road
Allendale
NJ
07401
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Lonza, Inc (USA)
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20796315
Publication citations
-
Results
Udani JK, Singh BB, Barrett ML, Singh VJ, Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers., Nutr J, 2010, 9, 32, doi: 10.1186/1475-2891-9-32.