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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roskamp Institute Inc.
ClinicalTrials.gov Identifier:
NCT01607619
First received: February 3, 2012
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Inflammation
 Dietary Supplement: Anatabine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roskamp Institute Inc.:

Primary Outcome Measures:
  • Blood levels of hsCRP [ Time Frame: Days 1, 14, 42, 70 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood levels of inflammatory markers [ Time Frame: Days 1, 14, 42, 70 ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: May 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Anatabine
    1mg anatabine in a mint-flavored mannitol lozenge
    Other Name: RCP006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607619

Locations
United States, Florida
The Roskamp Institute, Inc.
Sarasota, Florida, United States, 34243
United States, Michigan
McLaren Community Medical Center
Flint, Michigan, United States, 48532
Medical Practice
Shelby Township, Michigan, United States, 48315
Sponsors and Collaborators
Roskamp Institute Inc.
Investigators
Principal Investigator: Dale Wilson, MD McLaren Community Medical Center
Principal Investigator: Vittorio Morreale, MD Medical Practice, Shelby Township
  More Information

No publications provided

Responsible Party: Roskamp Institute Inc.
ClinicalTrials.gov Identifier: NCT01607619     History of Changes
Other Study ID Numbers: RI-11-01
Study First Received: February 3, 2012
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Roskamp Institute Inc.:
CRP

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013