Condition category
Haematological Disorders
Date applied
05/04/2011
Date assigned
15/04/2011
Last edited
06/09/2011
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

LONZ1400

Study information

Scientific title

Validation study of the immunomodulatory effects of ResistAid™: a randomised, double-blind, placebo-controlled, dose-finding study

Acronym

LONZ1400

Study hypothesis

ResistAid™ will enhance the immune response to a standardised antigenic challenge (Tetanus vaccine and Influenza vaccine) in a dose dependent manner compared with placebo.

Ethics approval

Copernicus Group IRB (Cary, NC) approved on 10th February 2010

Study design

Randomised double-blind parallel group clinical controlled trial

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 contact, Studies@staywellresearch.com to request a patient information sheet

Condition

Immunomodulation

Intervention

There are 3 arms to the study. Based on the randomisation, subjects will be assigned to ResistAid™1.5g, ResistAid™4.5g, Placebo (Maltodextrin)

Intervention type

Drug

Phase

Not Applicable

Drug names

ResistAid™

Primary outcome measures

Immune responses will be measured by Tetanus IgG
These serum markers will be measured upon screening, and again 15 days and 30 days after the vaccines have been administered.

Secondary outcome measures

Immune responses will be measured by:
Influenza A IgM
Influenza A IgG
Influenza B IgM
Influenza B IgG
These serum markers will be measured upon screening, and again 15 days and 30 days after the vaccines have been administered.

Overall trial start date

28/05/2010

Overall trial end date

09/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subjects must be between 18-65 years of age
2. Subject is willing to maintain his habitual food and beverage intake (other than substitution of study food for similar products) and physical activity patterns throughout the study period
3. Body mass index (BMI) between 18 and 30 kg/m2
4. Judged by the Investigator to be in general good health on the basis of medical history
5. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorisation for release of relevant protected health information to the study investigator
6. Females must agree to use approved birth control methods during the study
7. Subjects must not have had the Influenza vaccine for the 2009-2010 flu season
8. Subjects must not have had the Tetanus vaccine within the last 5 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

1. Subjects with any history of immune system disorder or auto-immune disorder including but not limited to the following:
Acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV), ankylosing spondylitis, chronic fatigue syndrome, CREST syndrome, crohn’s disease, dermatomyositis, fibromyalgia, grave’s disease, hashimoto’s thyroiditis, lupus, multiple sclerosis, myasthenia gravis, pernicious anaemia, polyarteritis nodosa, primary biliary cirrhosis, psoriasis, reynaud’s syndrome, rheumatoid arthritis, sarcoidosis, scleroderma, sjogren’s syndrome, temporal arthritis, ulcerative colitis and vitiligo
2. Known allergy or sensitivity to any ingredients in the study products
3. Subjects with history of using diabetic medications during the last 4 weeks to start of study
4. Subjects with history of using insulin during the last 12 weeks to start of study
5. Any active infection, or infection in the last month requiring antibiotics, anti-viral medication or hospitalisation
6. Subjects with active eating disorder including anorexia nervosa, bulimia and/or obsessive compulsive eating disorders
7. Subjects with untreated significant depression or other psychiatric disease noted during the initial screening. Subjects with stable depression who are receiving medication and/or therapy may be included
8. Subjects with unstable coronary artery disease, unstable congestive heart failure, stroke, unstable arrythmia, or uncontrolled hypertension
9. Subjects who are pregnant or breast-feeding
10. Subjects with history of seizure
11. Subjects on anticoagulation therapy
12. Recent history of (within 12 months) or strong potential for alcohol or substance abuse
13. Subjects with inflammatory bowel disease (ulcerative colitis or crohn’s disease)
14. Subjects with a history of perforation of the stomach or intestines
15. Subjects with brain and/or spinal cord injury
16. Untreated or unstable hypothyroidism
17. History or presence of cancer in the last 5 years, except for non-melanoma skin cancer
18. Use of any immunosuppressive drugs in the last 5 years
19. Steroids, biologics, etc
20. Any physical trauma in the last 4 months (including but not limited to motor vehicle accident or any physical injury)
21. Surgery within the last 6 months
22. Any clinically significant burn within the last 6 months
23. Current use of Insulin or use of Insulin in the past 3 years
24. Weight loss of more than or equal to 20 pounds in the last 3 months
25. Oestrogens—are allowed as long as there has been no change in the dose or frequency in the last 6 months
26. Subjects with a history of symptomatic hypoglycemia in the past 1 month
27. Abnormal physical examination
28. Participation in a clinical study with exposure to any non-registered drug product within 30 days prior
29. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
30. Subjects unable to understand or follow the study protocol

Recruitment start date

28/05/2010

Recruitment end date

09/12/2010

Locations

Countries of recruitment

United States of America

Trial participating centre

18250 Roscoe Blvd.
Northridge
91325
United States of America

Sponsor information

Organisation

Lonza (USA)

Sponsor details

90 Boroline Road
Allendale
07401
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Lonza (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

Publication citations

Additional files

Editorial Notes