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Red Clover Botanical Dietary Supplements - Metabolism and Safety in Women

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: NCT03205787
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Elena Barengolts, University of Illinois at Chicago

Brief Summary:
Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a red clover dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) will be given with four selected FDA-approved drugs to determine if the red clover supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predict that the red clover supplement might affect the metabolism or break down of these probe drugs.

Condition or disease Intervention/treatment Phase
Food-drug Interaction Dietary Supplement: Trifolium pratense Not Applicable

Detailed Description:
At the start of a study, subjects will be administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples will be drawn and analyzed for the concentration of each drug over time. Afterwards, participants will take the red clover dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs will be taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement would indicate that metabolism of the probe drugs is impacted by the red clover dietary supplement.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Red Clover Botanical Dietary Supplements - Metabolism and Safety in Women
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Red clover

Arm Intervention/treatment
Experimental: Trifolium pratense
Red clover extract; 2 gelatin capsules (398 mg extract) per day for 14 days
Dietary Supplement: Trifolium pratense
Red Clover extract standardized to isoflavone content.
Other Name: Red Clover




Primary Outcome Measures :
  1. Area Under the Curve (AUC) [ Time Frame: baseline and 14 days ]
    Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate area under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.


Secondary Outcome Measures :
  1. Apparent Clearance [ Time Frame: baseline and 14 days ]
    Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate apparent clearance of probe drug to determine any changes compared to pre-intervention.

  2. Peak Concentration [ Time Frame: baseline and 14 days ]
    Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate peak concentration of probe drug to determine any changes compared to pre-intervention.

  3. Time for Peak Concentration [ Time Frame: baseline and 14 days ]
    Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate time for peak concentration of probe drug to determine any changes compared to pre-intervention.

  4. Drug Half-life [ Time Frame: baseline and 14 days ]
    Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate half-life of probe drug to determine any changes compared to pre-intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy peri- and post-menopausal women ages 40 - 79
  • non-smokers
  • no-significant medical conditions as assessed by subject-reported medical history, physical examination and blood and urine chemistry screens
  • no medical condition that requires chronic use of medication

Exclusion Criteria:

  • known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, or red clover
  • positive pregnancy test
  • use of hormone therapy within 8 weeks of study initiation for oral agents, 4 weeks for transdermal or other topical agents
  • use of caffeine products 7 days before study participation or during the study
  • use of citrus products 7 days before study participation or during the study
  • other prescription (with the exception of the Mirena® IUD) or non-prescription medicines within the 2 weeks prior to study initiation or during the study
  • chronic diseases, such as inflammatory bowel disease, that could alter the absorption or metabolism of the probe substrates
  • unwillingness to comply with study requirements
  • current participation in another clinical trial
  • CYP2D6 deficiency based on phenotyping at screening
  • smoker
  • red clover or soy intake (whether as a botanical dietary supplement, food, drink or otherwise) within the previous two weeks and during the study
  • use of any dietary supplements within the last 2 weeks prior to study initiation and during the study
  • extreme obesity (defined as >40 BMI)
  • alcohol or drug abuse
  • chronic diseases such as diabetes.

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): NCT03205787


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Elena Barengolts, PhD University of Illinois at Chicago

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Responsible Party: Elena Barengolts, Principle Investigator, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03205787     History of Changes
Other Study ID Numbers: 2017-0436
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No