ObesityPhase 1/25011NCT01057576
Safety and Efficacy Study of Tarragon on Insulin Action in Humans
A Phase 1/2 study testing An alcoholic extract of Artemisia dracunculus L. in people with Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Specific compounds in plants have been proposed to enhance human metabolism. The hypothesis of the study was to evaluated the effect of an extract of Russian tarragon and to determine is compounds in the plant can be measured in the serum of human subjects and whether the compound may improve human metabolism as… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- An alcoholic extract of Artemisia dracunculus L.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Criteria for Inclusion
Men and women with obesity and meeting all criteria listed below will be included in the study:
- Subjects >30 years of age
- Subjects not currently treated with diabetes medication
- Fasting blood glucose at time of screening of less than 126mg/dl
- Subjects with a Body Mass Index (BMI) > 32 and <45.
- Written Informed Consent obtained PRIOR to performing any screening tests or study procedures.
- Exclusion Criteria
- Subjects with a prior history of Type 2 diabetes.
- Women who are pregnant or who are lactating.
- Women of childbearing potential who are not using an effective method of birth control
- Type 1 diabetes.
- Subjects who are currently on thiazolidinediones (rosiglitazone or pioglitazone) or who have taken these agents in the previous 12 weeks.
- Subjects who are on concomitant therapy with glucocorticoids (except topical or inhalant glucocorticoids).
- Subjects with a history or evidence of significant gastrointestinal dysfunction
- Subjects who are taking concomitant therapy with medications known to be nephrotoxic, such as aminoglycosides, methicillin, and cyclosporin.
- Subjects who have evidence of clinically significant renal dysfunction or disease
- Subjects with clinically significant cardiovascular dysfunction and/or history
- Subjects who have evidence within the preceding 6 months of hepatic disease or dysfunction; hepatitis; jaundice; cirrhosis.
- Subjects with clinically significant pulmonary, neurologic, hematologic, immunologic, neoplastic or metabolic disease.
- Subjects with evidence or recurrence of malignancy within the past five years, other than excised basal cell carcinoma.
- Subjects for whom surgery is anticipated during the study period.
- Subjects with an history of substance abuse or alcoholism within the past 5 years, or significant psychiatric disorder that would interfere with the subject's ability to complete the study.
- Subjects who have donated blood during the month prior to study entry or planned during the study.
- Subjects who have participated in other studies using an investigational drug during the preceding 3 months.
- Subjects who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: The Effect of Artemisia Dracunculus L. on Insulin Sensitivity in Obese, Insulin-Resistant Human Subjects
Specific compounds in plants have been proposed to enhance human metabolism. The hypothesis of the study was to evaluated the effect of an extract of Russian tarragon and to determine is compounds in the plant can be measured in the serum of human subjects and whether the compound may improve human metabolism as suggested in animal studies.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- An alcoholic extract of Artemisia dracunculus L., Placebo
- Keywords
- bioactives, insulin, botanicals
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An alcoholic extract of Artemisia dracunculus L.Dietary supplement
capsule, daily dosing
PlaceboOther
capsule, daily dosage
| Study group | Role | What they receive |
|---|---|---|
| PMI 5011 | Experimental | An experimental group randomized to PMI 5011 Receives: Dietary Supplement: An alcoholic extract of Artemisia dracunculus L. |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: at study completion
Secondary outcomes (1)
plasma abundane of bioactives
Measured: at study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startMar 2006
- Primary completionMar 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Cefalu, MD, Pennington Biomedical Research Center
- Investigators
- William T Cefalu, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057576
- Sponsor's protocol ID
- PBRC 26006
- Acronym
- 5011
- Status last verified
- Apr 2016
- First submitted
- 25 Jan 2010
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Artemisia Dracunculus L. on Insulin Sensitivity in Obese, Insulin-Resistant Human Subjects
- ClinicalTrials.gov ID
- NCT01057576
- Acronym / sponsor ID
- 5011 / PBRC 26006
- Conditions
- Obesity
- Keywords
- bioactives, insulin, botanicals
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific compounds in plants have been proposed to enhance human metabolism. The hypothesis of the study was to evaluated the effect of an extract of Russian tarragon and to determine is compounds in the plant can be measured in the serum of human subjects and whether the compound may improve human metabolism as suggested in animal studies.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMI 5011 | Experimental | Dietary Supplement: An alcoholic extract of Artemisia dracunculus L.An experimental group randomized to PMI 5011 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An alcoholic extract of Artemisia dracunculus L.capsule, daily dosing | Dietary supplement | PMI 5011 |
| Placebocapsule, daily dosage | Other | Placebo |
Primary outcome
Insulin sensitivity
Time frame: at study completion
1 secondary outcome
plasma abundane of bioactives
Time frame: at study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T Cefalu, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing An alcoholic extract of Artemisia dracunculus L. in people with Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: at study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.