Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects
October 28, 2009 updated by: innoVactiv Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
-
Quebec, Canada, G1K 7P4
- Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
|
Capsule similar in shape, weight and color from active, once a day for 28 consecutive days
|
|
Experimental: Treated
|
300 mg daily, once a day for 28 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Occurrence of adverse events
Time Frame: Baseline, 14 days, 28 days
|
Baseline, 14 days, 28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum IgA titers
Time Frame: Baseline, 14 days, 28 days
|
Baseline, 14 days, 28 days
|
|
Salivary IgA titers
Time Frame: Baseline, 14 days, 28 days
|
Baseline, 14 days, 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
May 20, 2009
First Submitted That Met QC Criteria
May 20, 2009
First Posted (Estimate)
May 21, 2009
Study Record Updates
Last Update Posted (Estimate)
October 29, 2009
Last Update Submitted That Met QC Criteria
October 28, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 2006-RD-05-CLN1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.