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

NCT ID: NCT01607619

Last Updated: 2013-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-01-31

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.

Conditions

Inflammation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Interventions

Anatabine

1mg anatabine in a mint-flavored mannitol lozenge

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

RCP006

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roskamp Institute Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dale Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

McLaren Community Medical Center

Vittorio Morreale, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Practice, Shelby Township

Locations

The Roskamp Institute, Inc.

Sarasota, Florida, United States

McLaren Community Medical Center

Flint, Michigan, United States

Medical Practice

Shelby, Michigan, United States

Countries

United States

Other Identifiers

RI-11-01

Identifier Type: -

Identifier Source: org_study_id