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

Inflammation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607619
• Other study ID #: RI-11-01
• Status: Completed
• Phase: N/A
• First received: February 3, 2012
• Last updated: January 24, 2013
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Roskamp Institute Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• Anatabine
1mg anatabine in a mint-flavored mannitol lozenge

Locations

Country	Name	City	State
United States	McLaren Community Medical Center	Flint	Michigan
United States	The Roskamp Institute, Inc.	Sarasota	Florida
United States	Medical Practice	Shelby Township	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Roskamp Institute Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of hsCRP		Days 1, 14, 42, 70	No
Secondary	Blood levels of inflammatory markers		Days 1, 14, 42, 70	No