Safety and Efficacy Study of Tarragon on Insulin Action in Humans (5011)
|Obesity||Dietary Supplement: An alcoholic extract of Artemisia dracunculus L. Other: Placebo||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Artemisia Dracunculus L. on Insulin Sensitivity in Obese, Insulin-Resistant Human Subjects|
- Insulin sensitivity [ Time Frame: at study completion ]
- plasma abundane of bioactives [ Time Frame: at study completion ]
|Study Start Date:||March 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Experimental: PMI 5011
An experimental group randomized to PMI 5011
Dietary Supplement: An alcoholic extract of Artemisia dracunculus L.
capsule, daily dosing
Placebo Comparator: Placebo
capsule, daily dosage
Artemisia dracunculus L., often called Russian tarragon, is a wild specie and a close relative of common cooking tarragon (known as French tarragon or Artemisia dracunculus sativa or dracunculoides). Artemisia and, more specifically, Artemisia dracunculus, have a storied history of medicinal use in humans, particularly for treatment of diabetes. The Artemisia dracunculus extract described in this project as PMI-5011 was originally identified from a screening of extracts for hypoglycemic activity in diabetic mice as the most promising candidate for the development of a nutritional supplement for diabetes. The active compounds in the preparation are believed to be members of the sesquiterpene, lactone or flavanoid groups, of which the Artemisia family is well known. Preliminary data from our laboratory suggests that PMI-5011 may have significant effects to improve carbohydrate metabolism by enhancing molecular events of insulin action in skeletal muscle.
PMI-5011 is an herbal botanical dietary supplement prepared from Artemisia dracunculus L. (Russian Tarragon) to help maintain normal blood glucose concentrations. PMI-5011 is an ethanolic extract from fresh herb grown in standardized hydroponic conditions for maximum consistency and nutritional content. Artemisia is a large family of herbs with a rich history of safe medicinal and culinary use. PMI-5011 is able to significantly decrease blood glucose concentrations in Streptozotocin-induced diabetic mice and in genetically diabetic KK-Ay mice. The preparation does not, however, decrease blood glucose concentrations in non-diabetic mice or rats. The historical use of the plant and its extract suggest that it is safe and its non-toxicity has been confirmed with acute and chronic toxicity studies and non-mutagenicity confirmed with AMES testing. PMI-5011 may have several modes of action leading to its ability to decrease blood glucose concentrations in diabetic animals, suggesting it is comprised of several different nutrients that act synergistically. Some in vitro activities of PMI-5011 include the modulation of GLP-1 binding to its receptor and the stimulation of insulin-mediated glucose uptake into cultured skeletal muscle cells. PMI-5011 also decreases the expression of PEPCK in the liver of diabetic animals and may decrease hepatic glucose output as a result. Recently, in an in vitro assay identified that PMI 5011 may have potent effects to reduce phosphastase activities and thereby promote insulin sensitivity.
The overall objective of the study was to evaluate the effect of a high does of PMI 5011 in obese insulin resistant, yet non-diabetic subjects. The study is a double-blind, randomized, placebo-controlled, pilot study in which subjects will be randomized to receive either placebo or PMI-5011 (4 500mg caps/TID) for a total of 3 weeks of treatment. Each subject will continue on the same dosage of PMI-5011 or matching placebo for the entire duration of treatment.
For this pilot trial, a precise technique (hyperinsulinemic-euglycemic clamps) will be used to assess insulin sensitivity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057576
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||William T Cefalu, MD||Pennington Biomedical Research Center|