Immunomodulatory effects of a proprietary Arabinogalactan extract

ISRCTN	ISRCTN98817459
DOI	https://doi.org/10.1186/ISRCTN98817459
Protocol serial number	LONZ1000
Sponsor	Lonza, Inc (USA)
Funder	Lonza, Inc (USA)

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

Primary study design	Interventional
Study design	Randomised double-blind placebo controlled parallel group study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Immunomodulatory effects of a proprietary Arabinogalactan extract: a randomised double-blind placebo controlled parallel group study
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	Arabinogalactan extract (Resistaid™)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Oxidative stress via F2 isoprostance in urine. All outcomes measured at baseline, day 30, day 51, and day 72.
Completion date	01/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/08/2008
Date of final enrolment	01/12/2008

Locations

Countries of recruitment

United States of America

Study participating centre

18250 Roscoe Blvd. Suite 240

Northridge
91325
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes