Immunomodulatory effects of a proprietary Arabinogalactan extract

ISRCTN ISRCTN98817459
DOI https://doi.org/10.1186/ISRCTN98817459
Secondary identifying numbers LONZ1000
Submission date
21/07/2009
Registration date
19/08/2009
Last edited
05/11/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jay Udani
Scientific

18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America

Study information

Study designRandomised double-blind placebo controlled parallel group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleImmunomodulatory effects of a proprietary Arabinogalactan extract: a randomised double-blind placebo controlled parallel group study
Study objectivesThe 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(s)IRB approval was obtained from the Copernicus Group (Cary, NC) on the 2nd September 2008 (ref: MED4-08-256)
Health condition(s) or problem(s) studiedImmune response to the 23-valent pneumococcal vaccine
InterventionThis 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.

Resistaidâ„¢ 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Arabinogalactan extract (Resistaidâ„¢)
Primary outcome measureMeasurements 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 measuresOxidative stress via F2 isoprostance in urine. All outcomes measured at baseline, day 30, day 51, and day 72.
Overall study start date01/08/2008
Completion date01/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/08/2008
Date of final enrolment01/12/2008

Locations

Countries of recruitment

  • United States of America

Study participating centre

18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America

Sponsor information

Lonza, Inc (USA)
Industry

90 Boroline Road
Allendale, NJ
07401
United States of America

Website http://www.lonza.com
ROR logo "ROR" https://ror.org/04g4p0a45

Funders

Funder type

Industry

Lonza, Inc (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/08/2010 Yes No