NCT00906438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

Enrollment Period

3 months

First QC Date

May 20, 2009

Last Update Submit

October 28, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

    Baseline, 14 days, 28 days

Secondary Outcomes (2)

  • Serum IgA titers

    Baseline, 14 days, 28 days

  • Salivary IgA titers

    Baseline, 14 days, 28 days

Study Arms (2)

Control

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Treated

EXPERIMENTAL
Dietary Supplement: 2006-RD-05

Interventions

2006-RD-05DIETARY_SUPPLEMENT

300 mg daily, once a day for 28 consecutive days

Treated
PlaceboDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men or women aged 18 - 60
  • In good health
  • BMI between 20 and 30 kg/m2
  • Non-smoking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Québec, Quebec, G1K 7P4, Canada

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

May 1, 2009

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations

CA(1)