Validation study of the immunomodulatory effects of ResistAid™

ISRCTN ISRCTN12127589
DOI https://doi.org/10.1186/ISRCTN12127589
Protocol serial number LONZ1400
Sponsor Lonza (USA)
Funder Lonza (USA)
Submission date
05/04/2011
Registration date
15/04/2011
Last edited
06/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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 designInterventional
Study designRandomised double-blind parallel group clinical controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleValidation study of the immunomodulatory effects of ResistAid™: a randomised, double-blind, placebo-controlled, dose-finding study
Study acronymLONZ1400
Study objectivesResistAid™ 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(s)Copernicus Group IRB (Cary, NC) approved on 10th February 2010
Health condition(s) or problem(s) studiedImmunomodulation
InterventionThere are 3 arms to the study. Based on the randomisation, subjects will be assigned to ResistAid™1.5g, ResistAid™4.5g, Placebo (Maltodextrin)
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)ResistAid™
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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.

Completion date09/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexAll
Target sample size at registration75
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment28/05/2010
Date of final enrolment09/12/2010

Locations

Countries of recruitment

  • United States of America

Study participating centre

18250 Roscoe Blvd.
Northridge
91325
United States of America

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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