Healthy
Conditions
Brief summary
It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In addition, this trial will aim to determine if this intake is able ot improve serum and salivary IgA synthesis.
Interventions
DIETARY_SUPPLEMENT2006-RD-05
300 mg daily, once a day for 28 consecutive days
DIETARY_SUPPLEMENTPlacebo
Capsule similar in shape, weight and color from active, once a day for 28 consecutive days
Sponsors
innoVactiv Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or women aged 18 - 60 * In good health * BMI between 20 and 30 kg/m2 * Non-smoking
Exclusion criteria
* Allergic to study drug * Use of immune-modulating drugs * Uncontrolled hypertension (Systolic \> 140 or diastolic \> 90) * Women of childbearing age not using proper contraception, that is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events | Baseline, 14 days, 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Serum IgA titers | Baseline, 14 days, 28 days |
| Salivary IgA titers | Baseline, 14 days, 28 days |
Countries
Canada
Outcome results
None listed