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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906438
First Posted: May 21, 2009
Last Update Posted: October 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
innoVactiv Inc.
  Purpose
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.

Condition Intervention Phase
Healthy Dietary Supplement: 2006-RD-05 Dietary Supplement: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects

Further study details as provided by innoVactiv Inc.:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: Baseline, 14 days, 28 days ]

Secondary Outcome Measures:
  • Serum IgA titers [ Time Frame: Baseline, 14 days, 28 days ]
  • Salivary IgA titers [ Time Frame: Baseline, 14 days, 28 days ]

Estimated Enrollment: 50
Study Start Date: May 2009
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Dietary Supplement: Placebo
Capsule similar in shape, weight and color from active, once a day for 28 consecutive days
Experimental: Treated Dietary Supplement: 2006-RD-05
300 mg daily, once a day for 28 consecutive days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906438


Locations
Canada
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
Quebec, Canada, G1K 7P4
Sponsors and Collaborators
innoVactiv Inc.
  More Information

Responsible Party: Scientific Director, Health & Nutrition, innoVactiv inc.
ClinicalTrials.gov Identifier: NCT00906438     History of Changes
Other Study ID Numbers: 2006-RD-05-CLN1
First Submitted: May 20, 2009
First Posted: May 21, 2009
Last Update Posted: October 29, 2009
Last Verified: October 2009