Safety and Efficacy Study of Tarragon on Insulin Action in Humans

NCT01057576 | Completed Phase 1

• 1 other identifier: PBRC 26006
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 suggested in animal studies.

Conditions

Obesity

Keywords

bioactives; insulin; botanicals

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  at study completion

Secondary Outcomes (1)

• plasma abundane of bioactives

  at study completion

Study Arms (2)

PMI 5011

EXPERIMENTAL

An experimental group randomized to PMI 5011

Dietary Supplement: An alcoholic extract of Artemisia dracunculus L.

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

An alcoholic extract of Artemisia dracunculus L. DIETARY_SUPPLEMENT

capsule, daily dosing

PMI 5011

Placebo OTHER

capsule, daily dosage

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• William T Cefalu, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investgator

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 27, 2010
• Study Start: March 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: October 1, 2008
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

US (1)