Validation study of the immunomodulatory effects of ResistAid™
| ISRCTN | ISRCTN12127589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12127589 |
| Secondary identifying numbers | LONZ1400 |
- 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
Scientific
18250 Roscoe Blvd.
Suite 240
Northridge
91325
United States of America
Study information
| Study design | Randomised double-blind parallel group clinical controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact, Studies@staywellresearch.com to request a patient information sheet |
| Scientific title | Validation study of the immunomodulatory effects of ResistAid™: a randomised, double-blind, placebo-controlled, dose-finding study |
| Study acronym | LONZ1400 |
| Study objectives | 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(s) | Copernicus Group IRB (Cary, NC) approved on 10th February 2010 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ResistAid™ |
| Primary outcome measure | 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 study start date | 28/05/2010 |
| Completion date | 09/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 75 |
| Key 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 |
| Key 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, crohns disease, dermatomyositis, fibromyalgia, graves disease, hashimotos thyroiditis, lupus, multiple sclerosis, myasthenia gravis, pernicious anaemia, polyarteritis nodosa, primary biliary cirrhosis, psoriasis, reynauds syndrome, rheumatoid arthritis, sarcoidosis, scleroderma, sjogrens 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 crohns 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. Oestrogensare 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 enrolment | 28/05/2010 |
| Date of final enrolment | 09/12/2010 |
Locations
Countries of recruitment
- United States of America
Study participating centre
18250 Roscoe Blvd.
Northridge
91325
United States of America
91325
United States of America
Sponsor information
Lonza (USA)
Industry
Industry
90 Boroline Road
Allendale
07401
United States of America
"ROR" |
https://ror.org/04g4p0a45 |
|---|
Funders
Funder type
Industry
Lonza (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
