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

innoVactiv

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: 2006-RD-05

Study type: Interventional

Funder types: Industry

Identifiers

NCT00906438

2006-RD-05-CLN1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Treated

Experimental group

Treatment:

Dietary Supplement: 2006-RD-05