Evaluation of Soy-protein Russian Tarragon (Artemisia Dracunculus L.)
RT2
2 other identifiers
interventional
64
1 country
1
Brief Summary
Safety and tolerability of a soy-protein Russian Tarragon complex versus a placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 28, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 21, 2019
March 1, 2019
4.2 years
February 28, 2014
March 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Levels of bioactive components from the Russian Tarragon Nutrasorb in the blood and urine
on average weekly for 3 weeks
Secondary Outcomes (1)
Glucose tolerance measured with an OGTT
on average weekly for 3 weeks
Study Arms (18)
Single Dose Sequence 1
EXPERIMENTALDose 1, Dose 2, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Single Dose Sequence 2
EXPERIMENTALDose 1, Dose 0, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Single Dose Sequence 3
EXPERIMENTALDose 0, Dose 1, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Single Dose Sequence 4
EXPERIMENTALDose 3, Dose 4, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Single Dose Sequence 5
EXPERIMENTALDose 3, Dose 0, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Single Dose Sequence 6
EXPERIMENTALDose 0, Dose 3, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Single Dose Sequence 7
EXPERIMENTALDose 5, Dose 6, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Single Dose Sequence 8
EXPERIMENTALDose 5, Dose 0, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Single Dose Sequence 9
EXPERIMENTALDose 0, Dose 5, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Multiple Dose Sequence 1
EXPERIMENTALDose 1, Dose 0, Dose 2: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Multiple Dose Sequence 2
EXPERIMENTALDose 1, Dose 2, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Multiple Dose Sequence 3
EXPERIMENTALDose 0, Dose 1, Dose 2: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Multiple Dose Sequence 4
EXPERIMENTALDose 2, Dose 0, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Multiple Dose Sequence 5
EXPERIMENTALDose 2, Dose 6, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Multiple Dose Sequence 6
EXPERIMENTALDose 0, Dose 2, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Multiple Dose Sequence 7
EXPERIMENTALDose 1, Dose 0, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Multiple Dose Sequence 8
EXPERIMENTALDose 1, Dose 6, Dose 0: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Multiple Dose Sequence 9
EXPERIMENTALDose 0, Dose 1, Dose 6: Each subject will receive daily doses for 21 consecutive days during each of three separate test periods.
Interventions
Russian Tarragon Nutrasorb 0.3 g
Russian Tarragon Nutrasorb 1 g
Placebo
Russian Tarragon Nutrasorb 3 g
Russian Tarragon Nutrasorb 10 g
Russian Tarragon Nutrasorb 20 g
Russian Tarragon Nutrasorb 30 g
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer C Rood, Ph.D.
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 28, 2014
First Posted
March 14, 2014
Study Start
February 1, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
March 21, 2019
Record last verified: 2019-03