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

• ClinicalTrials.gov Identifier: NCT01607619
• Recruitment Status: Completed
• First Posted: May 30, 2012
• Last Update Posted: January 28, 2013
• Sponsor: Roskamp Institute Inc.
• Information provided by (Responsible Party): Roskamp Institute Inc.

Tracking Information

• First Submitted Date: February 3, 2012
• First Posted Date: May 30, 2012
• Last Update Posted Date: January 28, 2013
• Study Start Date: May 2011
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 29, 2012): Blood levels of hsCRP [ Time Frame: Days 1, 14, 42, 70 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 29, 2012): Blood levels of inflammatory markers [ Time Frame: Days 1, 14, 42, 70 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Supportive Care
• Condition: Inflammation

Intervention

Dietary Supplement: Anatabine

1mg anatabine in a mint-flavored mannitol lozenge

Other Name: RCP006

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2013): 117
• Original Estimated Enrollment (submitted: May 29, 2012): 200
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01607619
• Other Study ID Numbers: RI-11-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Roskamp Institute Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Roskamp Institute Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dale Wilson, MD; McLaren Community Medical Center
• Principal Investigator: Vittorio Morreale, MD; Medical Practice, Shelby Township

• PRS Account: Roskamp Institute Inc.
• Verification Date: January 2013