Condition category
Respiratory
Date applied
21/07/2009
Date assigned
19/08/2009
Last edited
05/11/2010
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

Dr Jay Udani

ORCID ID

Contact details

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

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.

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 type

Drug

Phase

Not Specified

Drug names

Arabinogalactan extract (Resistaidâ„¢)

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

http://www.lonza.com

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

  1. 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.

Additional files

Editorial Notes