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Effect of Anatabine on Elevated Blood Levels of C-reactive Protein

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anatabine
Sponsored by
Roskamp Institute Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammation focused on measuring CRP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy adults with elevated blood levels of hsCRP

Exclusion Criteria:

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

Sites / Locations

  • The Roskamp Institute, Inc.
  • McLaren Community Medical Center
  • Medical Practice

Outcomes

Primary Outcome Measures

Blood levels of hsCRP

Secondary Outcome Measures

Blood levels of inflammatory markers

Full Information

First Posted
February 3, 2012
Last Updated
January 24, 2013
Sponsor
Roskamp Institute Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01607619
Brief Title
Effect of Anatabine on Elevated Blood Levels of C-reactive Protein
Official Title
A 12-week Multi-site Trial of the Dietary Supplement Anatabine (RCP006) to Determine the Effects on Peripheral Markers of Inflammation in Patients With Elevated Levels of C-reactive Protein (CRP)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roskamp Institute Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The investigators are studying a dietary supplement called anatabine which for the purposes of this study has been made into lozenges and named RCP006. Anatabine, the only active ingredient of RCP006, occurs throughout the world in the human food chain. Anatabine has been in the human food supply and in human use for centuries. Humans are exposed to anatabine in tobacco products and common and widely consumed food crops such as potatoes, peppers, eggplants and tomatoes. The main purpose of this study is to evaluate the effects of this dietary supplement on normal human inflammatory function. Compounds that are chemically similar to anatabine have been shown to reduce inflammatory responses, and laboratory studies show anti-inflammatory properties for anatabine. The investigators want to explore this further in human studies to see if anatabine can maintain normal levels of inflammatory function. The investigators will see this effect more easily if the investigators look at the effects of anatabine in volunteers who have markers of higher levels of inflammation to begin with. The investigators anticipate that anatabine will reduce markers of inflammation. To look for inflammation the investigators will test blood levels of a protein called C-reactive protein. C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Therefore the investigators are looking for volunteers with high blood levels of CRP and will monitor the blood CRP levels at several timepoints throughout the study. The investigators will also collect blood samples to measure other indicators of inflammation, and to measure blood levels of anatabine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
CRP

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Anatabine
Other Intervention Name(s)
RCP006
Intervention Description
1mg anatabine in a mint-flavored mannitol lozenge
Primary Outcome Measure Information:
Title
Blood levels of hsCRP
Time Frame
Days 1, 14, 42, 70
Secondary Outcome Measure Information:
Title
Blood levels of inflammatory markers
Time Frame
Days 1, 14, 42, 70

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy adults with elevated blood levels of hsCRP Exclusion Criteria: pregnancy or planning pregnancy current tobacco use current steroid use allergy to study product components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale Wilson, MD
Organizational Affiliation
McLaren Community Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vittorio Morreale, MD
Organizational Affiliation
Medical Practice, Shelby Township
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Roskamp Institute, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
McLaren Community Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Medical Practice
City
Shelby Township
State/Province
Michigan
ZIP/Postal Code
48315
Country
United States

12. IPD Sharing Statement

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Effect of Anatabine on Elevated Blood Levels of C-reactive Protein

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