Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
innoVactiv Inc.
ClinicalTrials.gov Identifier:
NCT00906438
First received: May 20, 2009
Last updated: October 28, 2009
Last verified: October 2009

May 20, 2009
October 28, 2009
May 2009
August 2009   (final data collection date for primary outcome measure)
Occurrence of adverse events [ Time Frame: Baseline, 14 days, 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00906438 on ClinicalTrials.gov Archive Site
  • Serum IgA titers [ Time Frame: Baseline, 14 days, 28 days ] [ Designated as safety issue: No ]
  • Salivary IgA titers [ Time Frame: Baseline, 14 days, 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects
Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
  • Dietary Supplement: 2006-RD-05
    300 mg daily, once a day for 28 consecutive days
  • Dietary Supplement: Placebo
    Capsule similar in shape, weight and color from active, once a day for 28 consecutive days
  • Placebo Comparator: Control
    Intervention: Dietary Supplement: Placebo
  • Experimental: Treated
    Intervention: Dietary Supplement: 2006-RD-05
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00906438
2006-RD-05-CLN1
Not Provided
Scientific Director, Health & Nutrition, innoVactiv inc.
innoVactiv Inc.
Not Provided
Not Provided
innoVactiv Inc.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP