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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01607619
Enrollment
117
Registered
2012-05-30
Start date
2011-05-31
Completion date
2013-01-31
Last updated
2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

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.

Interventions

DIETARY_SUPPLEMENTAnatabine

1mg anatabine in a mint-flavored mannitol lozenge

Sponsors

Roskamp Institute Inc.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Blood levels of hsCRPDays 1, 14, 42, 70

Secondary

MeasureTime frame
Blood levels of inflammatory markersDays 1, 14, 42, 70

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026