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

NCT ID: NCT00906438

Last Updated: 2009-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-10-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Capsule similar in shape, weight and color from active, once a day for 28 consecutive days

Treated

Group Type EXPERIMENTAL

2006-RD-05

Intervention Type DIETARY_SUPPLEMENT

300 mg daily, once a day for 28 consecutive days

Interventions

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2006-RD-05

300 mg daily, once a day for 28 consecutive days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Capsule similar in shape, weight and color from active, once a day for 28 consecutive days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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innoVactiv Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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innoVactiv inc.

Locations

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Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2006-RD-05-CLN1

Identifier Type: -

Identifier Source: org_study_id