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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: 2006-RD-05

• Registration Number: NCT00906438
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2009-08
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-28
• Last Update Posted: 2009-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Treated	2006-RD-05	-

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	Baseline, 14 days, 28 days

Secondary Outcome Measures

Name	Time	Method
Serum IgA titers	Baseline, 14 days, 28 days
Salivary IgA titers	Baseline, 14 days, 28 days

Trial Locations

Locations (1)

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF); 🇨🇦 Quebec, Canada