Evaluation of Soy-protein Russian Tarragon (Artemisia Dracunculus L.) Complex as a Dietary Supplement to Improve Carbohydrate Metabolism; Dosing, Safety and Tolerability
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Levels of bioactive components from the Russian Tarragon Nutrasorb in the blood and urine
Study Overview
Brief Summary
Safety and tolerability of a soy-protein Russian Tarragon complex versus a placebo.
Detailed Description
Plants from the genus Artemisia, and specifically Artemisia dracunculus L. (Russian tarragon) have had a long history of medicinal (health) and culinary (food) use and have been reported as effective as a traditional treatments for diabetes in various parts of the world. The overall objective of this study is to conduct early human investigation and to evaluate the effect of nutritional supplementation with a well characterized extract of Artemisia dracunculus L. The primary objectives would be to evaluate safety, tolerability and effective dose in non-diabetic human subjects. Secondary objectives would assess metabolism of the extract and evaluate effects on proposed mechanisms such as insulin secretion, lipid levels and/or insulin resistance.
Single Oral Dose Evaluation
After completing a screening visit and meeting qualifications for the single oral dose evaluation, subjects will receive three single doses (two different doses of the supplement and one dose of placebo) on three separate test periods which are separated by a washout period of at least 7 days. Each testing period requires an overnight stay on the inpatient unit. The inpatient stay will be approximately 26 hours. The doses that will be used in the study are 0.3, 1, 3, 10, 20 and 30 grams plus the placebo. The supplement and the placebo will be mixed with sugar-free flavoring in water. There will be an opportunity to sample the liquid drink during the screening visit.
Screening Visit 1 (about 1 hour) - Fasting (Nothing to eat or drink other than water for at least 10 hours prior to appointment)
- Sign informed consent if willing to participate
- Body weight and height will be measured (body mass index will be calculated from these measures)
- Blood pressure, pulse and temperature will be measured
- Physical exam and ECG (electrocardiogram)
- Report any medications taken over the past 3 months
- Blood draw (about 2 teaspoons) to assess overall health
- Taste test
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Are an overall healthy adult
- •Are male or female, ages 18-65 at time of consent
- •Are female and of childbearing potential, you must agree to use one of the approved contraception method [(i.e., barrier method, intrauterine and cervical devices, oral contraceptives, hormonal injections (Depo Provera®), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence)], prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.
- •Have a BMI within the range 18.5-40 kg/m2 (this is a measure of your height to weight ratio).
- •Are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Have no significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, endocrine, neurological and psychiatric disease
- •Have overall normal clinical laboratory tests as deemed by the physician
Exclusion Criteria
- •Have a prior history of Type 1 or 2 diabetes
- •Are a female who is pregnant or lactating.
- •Are taking certain medications (these will be reviewed with you by the study staff).
- •Are anticipating or planning to have surgery during the study period.
- •Are a current smoker or have smoked within the previous 6 months.
- •Have had a weight change of more than 5% in the last 2 months.
- •Are taking prescription or over the counter medications or supplements for weight loss.
Arms & Interventions
Single Dose Sequence 1
Dose 1, Dose 2, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Single Dose Sequence 1
Dose 1, Dose 2, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Single Dose Sequence 1
Dose 1, Dose 2, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 2
Dose 1, Dose 0, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Single Dose Sequence 2
Dose 1, Dose 0, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Single Dose Sequence 2
Dose 1, Dose 0, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 3
Dose 0, Dose 1, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Single Dose Sequence 3
Dose 0, Dose 1, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Single Dose Sequence 3
Dose 0, Dose 1, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 4
Dose 3, Dose 4, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 4
Dose 3, Dose 4, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 3 (Dietary Supplement)
Single Dose Sequence 4
Dose 3, Dose 4, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 4 (Dietary Supplement)
Single Dose Sequence 5
Dose 3, Dose 0, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 5
Dose 3, Dose 0, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 3 (Dietary Supplement)
Single Dose Sequence 5
Dose 3, Dose 0, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 4 (Dietary Supplement)
Single Dose Sequence 6
Dose 0, Dose 3, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 6
Dose 0, Dose 3, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 3 (Dietary Supplement)
Single Dose Sequence 6
Dose 0, Dose 3, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 4 (Dietary Supplement)
Single Dose Sequence 7
Dose 5, Dose 6, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 7
Dose 5, Dose 6, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 5 (Dietary Supplement)
Single Dose Sequence 7
Dose 5, Dose 6, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Single Dose Sequence 8
Dose 5, Dose 0, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 8
Dose 5, Dose 0, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 5 (Dietary Supplement)
Single Dose Sequence 8
Dose 5, Dose 0, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Single Dose Sequence 9
Dose 0, Dose 5, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Single Dose Sequence 9
Dose 0, Dose 5, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 5 (Dietary Supplement)
Single Dose Sequence 9
Dose 0, Dose 5, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Multiple Dose Sequence 1
Dose 1, Dose 0, Dose 2: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Multiple Dose Sequence 1
Dose 1, Dose 0, Dose 2: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Multiple Dose Sequence 1
Dose 1, Dose 0, Dose 2: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 2
Dose 1, Dose 2, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Multiple Dose Sequence 2
Dose 1, Dose 2, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Multiple Dose Sequence 2
Dose 1, Dose 2, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 3
Dose 0, Dose 1, Dose 2: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Multiple Dose Sequence 3
Dose 0, Dose 1, Dose 2: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Multiple Dose Sequence 3
Dose 0, Dose 1, Dose 2: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 4
Dose 2, Dose 0, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Multiple Dose Sequence 4
Dose 2, Dose 0, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 4
Dose 2, Dose 0, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Multiple Dose Sequence 5
Dose 2, Dose 6, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Multiple Dose Sequence 5
Dose 2, Dose 6, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 5
Dose 2, Dose 6, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Multiple Dose Sequence 6
Dose 0, Dose 2, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 2 (Dietary Supplement)
Multiple Dose Sequence 6
Dose 0, Dose 2, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 6
Dose 0, Dose 2, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Multiple Dose Sequence 7
Dose 1, Dose 0, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Multiple Dose Sequence 7
Dose 1, Dose 0, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 7
Dose 1, Dose 0, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Multiple Dose Sequence 8
Dose 1, Dose 6, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Multiple Dose Sequence 8
Dose 1, Dose 6, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 8
Dose 1, Dose 6, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Multiple Dose Sequence 9
Dose 0, Dose 1, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 1 (Dietary Supplement)
Multiple Dose Sequence 9
Dose 0, Dose 1, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 0 (Dietary Supplement)
Multiple Dose Sequence 9
Dose 0, Dose 1, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Intervention: Dose 6 (Dietary Supplement)
Outcomes
Primary Outcomes
Levels of bioactive components from the Russian Tarragon Nutrasorb in the blood and urine
Time Frame: on average weekly for 3 weeks
Secondary Outcomes
- Glucose tolerance measured with an OGTT(on average weekly for 3 weeks)
Investigators
Jennifer C. Rood
Principal Investigator
Pennington Biomedical Research Center