NCT01607619

Brief Summary

The investigators are studying a dietary supplement called anatabine in a lozenge form named RCP006. The main purpose of this study is to evaluate the effects of this dietary supplement on normal human inflammatory function. The investigators will see this effect in volunteers who have markers of higher levels of inflammation to begin with. The investigators anticipate that anatabine will reduce markers of inflammation. Therefore the investigators are looking for volunteers with high blood levels of C-reactive Protein (CRP) and will monitor the blood CRP levels at several time points throughout the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

3 active sites

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, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

February 3, 2012

Last Update Submit

January 24, 2013

Conditions

Inflammation

Keywords

CRP

Outcome Measures

Primary Outcomes (1)

  • Blood levels of hsCRP

    Days 1, 14, 42, 70

Secondary Outcomes (1)

  • Blood levels of inflammatory markers

    Days 1, 14, 42, 70

Interventions

AnatabineDIETARY_SUPPLEMENT

1mg anatabine in a mint-flavored mannitol lozenge

Also known as: RCP006

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults with elevated blood levels of hsCRP

You may not qualify if:

  • pregnancy or planning pregnancy
  • current tobacco use
  • current steroid use
  • allergy to study product components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Roskamp Institute, Inc.

Sarasota, Florida, 34243, United States

Location

McLaren Community Medical Center

Flint, Michigan, 48532, United States

Location

Medical Practice

Shelby, Michigan, 48315, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

anatabine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dale Wilson, MD

    McLaren Community Medical Center

    PRINCIPAL INVESTIGATOR

  • Vittorio Morreale, MD

    Medical Practice, Shelby Township

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2012

First Posted

May 30, 2012

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

US(3)