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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Prevention

In brief

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

Key facts

Study ID

NCT02088203

Run by

Pennington Biomedical Research Center

People needed

64

Starts

2014-02-01

Expected to finish

2018-05-01

Last updated by the study team

2019-03-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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