HealthyKLBIONCT02264223
The Bioavailability of Red Clover Isoflavones
A study testing Fermented red clover isoflavones in aglycone form and Unfermented glycosides (as aglycone equivalents) in people with Healthy, run by University of Aarhus at 1 site in Denmark.
Trial summary
Previous literature has shown that the molecular form of isoflavones (as aglycones or glycosides) and food matrices can influence the bioavailability of these compounds in humans and hence their efficacy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fermented red clover isoflavones in aglycone form and Unfermented glycosides (as aglycone equivalents)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to May 2022
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women
- Age: 18-40 years
Who cannot join
- Habitual intake of soy products, chickpeas or other supplements with a high content of isoflavones
- Hormone therapy
- Pregnant or breastfeeding
- Taking drugs affecting uptake
- Participation in other clinical trials within the last 3 months
- Severe cardiovascular, psychiatric, neurological and / or kidney disease
- Alcohol or substance abuse
- Acute illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Processing and Matrices on Bioavailability of Red Clover Isoflavones in Healthy Women
Previous literature has shown that the molecular form of isoflavones (as aglycones or glycosides) and food matrices can influence the bioavailability of these compounds in humans and hence their efficacy. To determine the effects of processing and food matrices on the bioavailability of active compounds derived from red clover the investigators will execute a 5 phase, cross-over design, open label, RCT using 20 healthy women aged between 18 to 40 years. Participants will receive 5 different formulations of red clover and bioavailability will be monitored in blood plasma using LC-MS.
Read the detailed description
The aim of this study is to elucidate the effects food matrices and processing on the bioavailability of active compounds on the bioavailability of red clover derived isoflavones. 20 healthy participants will receive red clover derived isoflavones in five different formulations. The five formulations are split up into five phases:
Phase 1) Fermented extract in liquid form Phase 2) Fermented extract (freeze-dried) in capsule form Phase 3) Fermented extract (freeze-dried) in tablet form Phase 4) Fermented extract (concentrated) mixed in yogurt Phase 5) Un-fermented red clover in capsule or tablet form The trial will last 5-6 weeks for each participant. Plasma sample collection will take place both pre-and post- ingestion of a formulation, participants will receive blood tests at intervals -15 min, 0 min, 2hr, 4hr, 6hr, 8hr and 12hr (on the day of ingestion) and on the subsequent two mornings (24hr and 48hr) following the initiation of a phase. There will be a minimum. 5 day intervals between all phases (washout periods). Isoflavones biochanin A, formononetin, genistein and daidzein present in plasma will be detected using HPLC-MS for each phase, thus creating a bioavailability curve that can be compared to each of the other phases. The primary endpoint is to determine whether fermented extract is more bioavailable than unfermented extract.
- Conditions
- Healthy
- Being tested
- Fermented red clover isoflavones in aglycone form, Unfermented glycosides (as aglycone equivalents)
- Keywords
- Bioavailability, Isoflavones, Plasma, Human, Processing, Cross-over
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented red clover isoflavones in aglycone formDietary supplement
Fermented isoflavones in aglycone form
Unfermented glycosides (as aglycone equivalents)Dietary supplement
Unfermented aglycone equivalents in glycoside form
| Study group | Role | What they receive |
|---|---|---|
| Capsule (aglycone) | Active comparator | single bolus 40mg isoflavone formulation of fermented extract in freeze-dried capsule.
Fermented red clover isoflavones in aglycone form Receives: Dietary Supplement: Fermented red clover isoflavones in aglycone form |
| Tablet (aglycone) | Active comparator | single bolus 40mg isoflavone aglycone formulation of fermented extract in freeze-dried tablet.
Fermented red clover isoflavones in aglycone form Receives: Dietary Supplement: Fermented red clover isoflavones in aglycone form |
| Yoghurt (aglycone) | Active comparator | single bolus 40mg isoflavone aglycone formulation of fermented extract mixed with yoghurt
Fermented red clover isoflavones in aglycone form Receives: Dietary Supplement: Fermented red clover isoflavones in aglycone form |
| Liquid extract (aglycone) | Active comparator | single bolus 40mg isoflavone aglycone formulation of fermented extract in liquid
Fermented red clover isoflavones in aglycone form Receives: Dietary Supplement: Fermented red clover isoflavones in aglycone form |
| Tablet unfermented (glycoside) | Active comparator | single bolus 40mg isoflavone aglycone equivalent tablet formulation of unfermented red clover isoflavones
Unfermented glycosides (as aglycone equivalents) Receives: Dietary Supplement: Unfermented glycosides (as aglycone equivalents) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of isoflavones in terms of fermented vs unfermented formulations
As measured by iAUC plasma concentrations of isoflavones over 48 hours
Measured: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr
Secondary outcomes (1)
Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid)
As measured by iAUC plasma concentrations of isoflavones over 48 hours
Measured: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Danish University, Herrens Mark A/S, Natur Drogeriet A/S, Future Food Innovation
- Responsible party
- Principal investigator, Per Bendix Jeppesen, University of Aarhus
- Investigators
- Per B Jeppesen, Prof. PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264223
- Sponsor's protocol ID
- KLBIO 07-10-14
- Acronym
- KLBIO
- Status last verified
- Dec 2015
- First submitted
- 8 Oct 2014
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Processing and Matrices on Bioavailability of Red Clover Isoflavones in Healthy Women
- ClinicalTrials.gov ID
- NCT02264223
- Acronym / sponsor ID
- KLBIO / KLBIO 07-10-14
- Conditions
- Healthy
- Keywords
- Bioavailability, Isoflavones, Plasma, Human, Processing, Cross-over
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Southern Danish University, Herrens Mark A/S, Natur Drogeriet A/S, Future Food Innovation
- Study start
- Oct 2014
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 15 Oct 2014 (estimated)
- 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.
Previous literature has shown that the molecular form of isoflavones (as aglycones or glycosides) and food matrices can influence the bioavailability of these compounds in humans and hence their efficacy. To determine the effects of processing and food matrices on the bioavailability of active compounds derived from red clover the investigators will execute a 5 phase, cross-over design, open label, RCT using 20 healthy women aged between 18 to 40 years. Participants will receive 5 different formulations of red clover and bioavailability will be monitored in blood plasma using LC-MS.
Detailed description
The aim of this study is to elucidate the effects food matrices and processing on the bioavailability of active compounds on the bioavailability of red clover derived isoflavones. 20 healthy participants will receive red clover derived isoflavones in five different formulations. The five formulations are split up into five phases:
Phase 1) Fermented extract in liquid form Phase 2) Fermented extract (freeze-dried) in capsule form Phase 3) Fermented extract (freeze-dried) in tablet form Phase 4) Fermented extract (concentrated) mixed in yogurt Phase 5) Un-fermented red clover in capsule or tablet form The trial will last 5-6 weeks for each participant. Plasma sample collection will take place both pre-and post- ingestion of a formulation, participants will receive blood tests at intervals -15 min, 0 min, 2hr, 4hr, 6hr, 8hr and 12hr (on the day of ingestion) and on the subsequent two mornings (24hr and 48hr) following the initiation of a phase. There will be a minimum. 5 day intervals between all phases (washout periods). Isoflavones biochanin A, formononetin, genistein and daidzein present in plasma will be detected using HPLC-MS for each phase, thus creating a bioavailability curve that can be compared to each of the other phases. The primary endpoint is to determine whether fermented extract is more bioavailable than unfermented extract.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Capsule (aglycone) | Active comparator | Dietary Supplement: Fermented red clover isoflavones in aglycone formsingle bolus 40mg isoflavone formulation of fermented extract in freeze-dried capsule. Fermented red clover isoflavones in aglycone form |
| Tablet (aglycone) | Active comparator | Dietary Supplement: Fermented red clover isoflavones in aglycone formsingle bolus 40mg isoflavone aglycone formulation of fermented extract in freeze-dried tablet. Fermented red clover isoflavones in aglycone form |
| Yoghurt (aglycone) | Active comparator | Dietary Supplement: Fermented red clover isoflavones in aglycone formsingle bolus 40mg isoflavone aglycone formulation of fermented extract mixed with yoghurt Fermented red clover isoflavones in aglycone form |
| Liquid extract (aglycone) | Active comparator | Dietary Supplement: Fermented red clover isoflavones in aglycone formsingle bolus 40mg isoflavone aglycone formulation of fermented extract in liquid Fermented red clover isoflavones in aglycone form |
| Tablet unfermented (glycoside) | Active comparator | Dietary Supplement: Unfermented glycosides (as aglycone equivalents)single bolus 40mg isoflavone aglycone equivalent tablet formulation of unfermented red clover isoflavones Unfermented glycosides (as aglycone equivalents) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women
- Age: 18-40 years
Key exclusion criteria (8 listed)
- Habitual intake of soy products, chickpeas or other supplements with a high content of isoflavones
- Hormone therapy
- Pregnant or breastfeeding
- Taking drugs affecting uptake
- Participation in other clinical trials within the last 3 months
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 |
|---|---|---|
| Fermented red clover isoflavones in aglycone formFermented isoflavones in aglycone form | Dietary supplement | Capsule (aglycone), Liquid extract (aglycone), Tablet (aglycone), Yoghurt (aglycone) |
| Unfermented glycosides (as aglycone equivalents)Unfermented aglycone equivalents in glycoside form | Dietary supplement | Tablet unfermented (glycoside) |
Primary outcome
Bioavailability of isoflavones in terms of fermented vs unfermented formulations
Time frame: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr
As measured by iAUC plasma concentrations of isoflavones over 48 hours
1 secondary outcome
Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid)
Time frame: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr
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 23 May 2022.
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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.
Per B Jeppesen, Prof. PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented red clover isoflavones in aglycone form and Unfermented glycosides (as aglycone equivalents) in people with Healthy, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 8 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 23 May 2022. 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 Denmark. 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?
Bioavailability of isoflavones in terms of fermented vs unfermented formulations (time frame: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2022.