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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by innoVactiv Inc.:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: Baseline, 14 days, 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906438

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

No publications provided

Responsible Party: Scientific Director, Health & Nutrition, innoVactiv inc.
ClinicalTrials.gov Identifier: NCT00906438     History of Changes
Other Study ID Numbers: 2006-RD-05-CLN1
Study First Received: May 20, 2009
Last Updated: October 28, 2009
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on August 21, 2014