Red Clover Botanical Dietary Supplements - Metabolism and Safety in Women

NCT03205787 | Completed DMC

• 1 other identifier: 2017-0436
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Human safety studies were 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) was 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 predicted that the red clover supplement might affect the metabolism or break down of these probe drugs.

Conditions

Food-drug Interaction

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC)

  Concentrations of probe drugs from blood draws at the conclusion of the 14-day intervention were used to calculate areas under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.

  baseline and 14 days

Secondary Outcomes (4)

• Apparent Clearance

  baseline and 14 days

• Peak Concentration

  baseline and 14 days

• Time for Peak Concentration

  baseline and 14 days

• Drug Half-life

  baseline and 14 days

Study Arms (1)

Trifolium pratense

EXPERIMENTAL

Red clover extract; 2 gelatin capsules (398 mg extract) per day for 14 days

Dietary Supplement: Trifolium pratense

Interventions

Trifolium pratense DIETARY_SUPPLEMENT

Red Clover extract standardized to isoflavone content.

Also known as: Red Clover

Trifolium pratense

Eligibility Criteria

• Age: 40 Years - 79 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Muchiri RN, van Breemen RB. Single-Laboratory Validation of UHPLC-MS/MS Assays for Red Clover Isoflavones in Human Serum and Dietary Supplements. J AOAC Int. 2020 Jul 1;103(4):1160-1166. doi: 10.1093/jaoacint/qsaa033.

  PMID: 33241325 RESULT

Study Officials

• Richard vanBreemen, PhD

  University of Illinois at Chicago

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: September 21, 2017
• Primary Completion: April 29, 2020
• Study Completion: July 1, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)