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Evaluation of Soy-protein Russian Tarragon (Artemisia Dracunculus L.) (RT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088203
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Jennifer C. Rood, Pennington Biomedical Research Center

Brief Summary:
Safety and tolerability of a soy-protein Russian Tarragon complex versus a placebo.

Condition or disease Intervention/treatment Phase
Diabetes Prevention Dietary Supplement: Dose 1 Dietary Supplement: Dose 2 Dietary Supplement: Dose 0 Dietary Supplement: Dose 3 Dietary Supplement: Dose 4 Dietary Supplement: Dose 5 Dietary Supplement: Dose 6 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Soy-protein Russian Tarragon (Artemisia Dracunculus L.) Complex as a Dietary Supplement to Improve Carbohydrate Metabolism; Dosing, Safety and Tolerability
Actual Study Start Date : February 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Dose Sequence 1
Dose 1, Dose 2, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Experimental: Single Dose Sequence 2
Dose 1, Dose 0, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Experimental: Single Dose Sequence 3
Dose 0, Dose 1, Dose 2: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Experimental: Single Dose Sequence 4
Dose 3, Dose 4, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 3
Russian Tarragon Nutrasorb 3 g

Dietary Supplement: Dose 4
Russian Tarragon Nutrasorb 10 g

Experimental: Single Dose Sequence 5
Dose 3, Dose 0, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 3
Russian Tarragon Nutrasorb 3 g

Dietary Supplement: Dose 4
Russian Tarragon Nutrasorb 10 g

Experimental: Single Dose Sequence 6
Dose 0, Dose 3, Dose 4: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 3
Russian Tarragon Nutrasorb 3 g

Dietary Supplement: Dose 4
Russian Tarragon Nutrasorb 10 g

Experimental: Single Dose Sequence 7
Dose 5, Dose 6, Dose 0: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 5
Russian Tarragon Nutrasorb 20 g

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g

Experimental: Single Dose Sequence 8
Dose 5, Dose 0, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 5
Russian Tarragon Nutrasorb 20 g

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g

Experimental: Single Dose Sequence 9
Dose 0, Dose 5, Dose 6: Each subject will receive a single dose during each of three separate test periods.
Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 5
Russian Tarragon Nutrasorb 20 g

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g

Experimental: 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.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Experimental: 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.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Experimental: 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.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Experimental: 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.
Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g

Experimental: 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.
Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g

Experimental: 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.
Dietary Supplement: Dose 2
Russian Tarragon Nutrasorb 1 g

Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g

Experimental: 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.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g

Experimental: 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.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g

Experimental: 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.
Dietary Supplement: Dose 1
Russian Tarragon Nutrasorb 0.3 g

Dietary Supplement: Dose 0
Placebo

Dietary Supplement: Dose 6
Russian Tarragon Nutrasorb 30 g




Primary Outcome Measures :
  1. Levels of bioactive components from the Russian Tarragon Nutrasorb in the blood and urine [ Time Frame: on average weekly for 3 weeks ]

Secondary Outcome Measures :
  1. Glucose tolerance measured with an OGTT [ Time Frame: on average weekly for 3 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088203


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
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Principal Investigator: Jennifer C Rood, Ph.D. Pennington Biomedical Research Center
  Study Documents (Full-Text)

Documents provided by Jennifer C. Rood, Pennington Biomedical Research Center:
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Responsible Party: Jennifer C. Rood, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02088203    
Other Study ID Numbers: PBRC 2013-049
P50AT002776 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided