Food-drug InteractionNCT03205787
Red Clover Botanical Dietary Supplements - Metabolism and Safety in Women
A study testing Trifolium pratense in people with Food-drug Interaction, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food-drug Interaction
- What is being tested?
- Trifolium pratense
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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.
Read the detailed description
At the start of a study, subjects were administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples were drawn and analyzed for the concentration of each drug over time. Afterwards, participants took the red clover dietary supplement twice orally daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs were 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 were evaluated to determine if metabolism of the probe drugs was impacted by the red clover dietary supplement.
- Conditions
- Food-drug Interaction
- Being tested
- Trifolium pratense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifolium pratenseDietary supplement
Also called Red Clover
Red Clover extract standardized to isoflavone content.
| Study group | Role | What they receive |
|---|---|---|
| Trifolium pratense | Experimental | Red clover extract; 2 gelatin capsules (398 mg extract) per day for 14 days Receives: Dietary Supplement: Trifolium pratense |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 14 days
Secondary outcomes (4)
Apparent Clearance
Concentrations of probe drugs from blood draws at the conclusion of the 14-day intervention were used to calculate changes in apparent clearance of each probe drug compared to pre-intervention.
Measured: baseline and 14 days
Peak Concentration
Concentrations of probe drugs from blood draws at the conclusion of the 14-day intervention were used to calculate changes in peak concentrations of probe drugs to compared to pre-intervention concentrations.
Measured: baseline and 14 days
Time for Peak Concentration
Concentrations of probe drugs from blood draws at the conclusion of the 14-day intervention were used to calculate changes in time for peak concentration of probe drugs compared to pre-intervention concentrations.
Measured: baseline and 14 days
Drug Half-life
Concentrations of probe drugs from blood draws at the end of the 14-day intervention were used to calculate half-lives of probe drugs to determine any changes compared to pre-intervention.
Measured: baseline and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start21 Sep 2017
- Primary completion29 Apr 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food-drug InteractionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Barengolts, University of Illinois Chicago
- Investigators
- Richard vanBreemen, PhD, Study director, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205787
- Sponsor's protocol ID
- 2017-0436
- Status last verified
- May 2021
- First submitted
- 29 Jun 2017
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33241325
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Clover Botanical Dietary Supplements - Metabolism and Safety in Women
- ClinicalTrials.gov ID
- NCT03205787
- Acronym / sponsor ID
- 2017-0436
- Conditions
- Food-drug Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At the start of a study, subjects were administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples were drawn and analyzed for the concentration of each drug over time. Afterwards, participants took the red clover dietary supplement twice orally daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs were 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 were evaluated to determine if metabolism of the probe drugs was impacted by the red clover dietary supplement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trifolium pratense | Experimental | Dietary Supplement: Trifolium pratenseRed clover extract; 2 gelatin capsules (398 mg extract) per day for 14 days |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifolium pratenseAlso: Red CloverRed Clover extract standardized to isoflavone content. | Dietary supplement | Trifolium pratense |
Primary outcome
Area Under the Curve (AUC)
Time frame: baseline and 14 days
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.
4 secondary outcomes
Apparent Clearance
Time frame: baseline and 14 days
Peak Concentration
Time frame: baseline and 14 days
Time for Peak Concentration
Time frame: baseline and 14 days
Drug Half-life
Time frame: baseline and 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Results publication: PubMed 33241325Muchiri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard vanBreemen, PhD study director
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifolium pratense in people with Food-drug Interaction, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) (time frame: baseline and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.