ISRCTN12127589
Completed
Not Applicable
Validation study of the immunomodulatory effects of ResistAid™: a randomised, double-blind, placebo-controlled, dose-finding study
onza (USA)0 sites75 target enrollmentApril 15, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Immunomodulation
- Sponsor
- onza (USA)
- Enrollment
- 75
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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