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OpenTrials
Completed

NCT Number: NCT00906438

Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Québec, Quebec, G1K 7P4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2006-RD-05

Dietary Supplement

300 mg daily, once a day for 28 consecutive days

Placebo

Dietary Supplement

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

Primary outcomes

  1. Occurrence of adverse events

    Time frame: Baseline, 14 days, 28 days

Secondary outcomes

  1. Serum IgA titers

    Time frame: Baseline, 14 days, 28 days

  2. Salivary IgA titers

    Time frame: Baseline, 14 days, 28 days

Sponsors and collaborators

Lead sponsor

innoVactiv Inc.

Industry

Registry information

Official study title

Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 21, 2009
Registry last updated
Oct 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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