Immunomodulatory Effects of ResistAid™: A Randomized, Double-Blind, Placebo-Controlled, Multidose Study

Figures & data

Table 1 Inclusion criteria, exclusion criteria, and study controls

Inclusion Criteria
Assessment of being in good health
BMI between 18 and 30 kg/m^2
Age between 18 and 60 years
Exclusion Criteria
Any major systemic, inflammatory, or chronic disease
Any active infection or infection in the past month requiring antibiotics or anti-viral medication
Used immunosuppressive drugs in the prior 5 years
Were known to have alcohol or drug abuse
Were pregnant or lactating
Allergy to eggs
Had any medical condition which in the opinion of the investigator might interfere with the subject's participation in the trial
Study Controls
Subjects asked to maintain their normal diet and exercise routine during study
Females were required to use an approved birth control method during the study
Subjects using dietary supplements designed to boost the immune system and/or multi-vitamins were required to discontinue these products for at least 2 weeks before entering the study.

Fig. 1 Study Attrition Chart. 108 study participants were screened and 75 completed the study.

Fig. 2 Tetanus IgG Antibody Level. All 3 groups demonstrated an increase in IgG levels at day 45. There was a strongly significant difference between the 1.5 g/day group and the placebo group in IgG levels at day 60 (p = 0.008).

Fig. 3 Influenza (A) IgG Antibody Level. All 3 groups demonstrated an expected physiological increase and peak in influenza A IgM by day 45 with a slight reduction at day 60. All 3 groups demonstrated an expected rise in influenza A IgG following the vaccine, which peaked at day 45 for the 4.5 g/day and placebo groups and at day 60 for the 1.5 g/day group.

Fig. 4 Influenza (B) IgG Antibody Level. All 3 groups demonstrated an expected increase in influenza B IgM after vaccination.