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

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. Identifier: NCT00906438
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : October 29, 2009
Information provided by:
innoVactiv Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: 2006-RD-05 Dietary Supplement: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

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 identifier (NCT number): NCT00906438

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

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Responsible Party: Scientific Director, Health & Nutrition, innoVactiv inc. Identifier: NCT00906438    
Other Study ID Numbers: 2006-RD-05-CLN1
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009