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Trial record 4 of 9 for:    red clover

The Bioavailability of Red Clover Isoflavones (KLBIO)

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ClinicalTrials.gov Identifier: NCT02264223
Recruitment Status : Unknown
Verified December 2015 by Per Bendix Jeppesen, University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2014
Last Update Posted : December 15, 2015
Sponsor:
Collaborators:
Southern Danish University
Herrens Mark A/S
Natur Drogeriet A/S
Future Food Innovation
Information provided by (Responsible Party):
Per Bendix Jeppesen, University of Aarhus

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Fermented red clover isoflavones in aglycone form Dietary Supplement: Unfermented glycosides (as aglycone equivalents) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Processing and Matrices on Bioavailability of Red Clover Isoflavones in Healthy Women
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Red clover

Arm Intervention/treatment
Active Comparator: Capsule (aglycone)

single bolus 40mg isoflavone formulation of fermented extract in freeze-dried capsule.

Fermented red clover isoflavones in aglycone form

Dietary Supplement: Fermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form

Active Comparator: Tablet (aglycone)

single bolus 40mg isoflavone aglycone formulation of fermented extract in freeze-dried tablet.

Fermented red clover isoflavones in aglycone form

Dietary Supplement: Fermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form

Active Comparator: Yoghurt (aglycone)

single bolus 40mg isoflavone aglycone formulation of fermented extract mixed with yoghurt

Fermented red clover isoflavones in aglycone form

Dietary Supplement: Fermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form

Active Comparator: Liquid extract (aglycone)

single bolus 40mg isoflavone aglycone formulation of fermented extract in liquid

Fermented red clover isoflavones in aglycone form

Dietary Supplement: Fermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form

Active Comparator: Tablet unfermented (glycoside)

single bolus 40mg isoflavone aglycone equivalent tablet formulation of unfermented red clover isoflavones

Unfermented glycosides (as aglycone equivalents)

Dietary Supplement: Unfermented glycosides (as aglycone equivalents)
Unfermented aglycone equivalents in glycoside form




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid) [ Time Frame: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr ]
    As measured by iAUC plasma concentrations of isoflavones over 48 hours



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy women
  • Age: 18-40 years

Exclusion Criteria:

  • 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

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): NCT02264223


Locations
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Denmark
Aarhus University Hospital
Aarhus, Central Jutland Region, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Southern Danish University
Herrens Mark A/S
Natur Drogeriet A/S
Future Food Innovation
Investigators
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Principal Investigator: Per B Jeppesen, Prof. PhD University of Aarhus

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Responsible Party: Per Bendix Jeppesen, Associate Prof., PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT02264223     History of Changes
Other Study ID Numbers: KLBIO 07-10-14
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Per Bendix Jeppesen, University of Aarhus:
Bioavailability
Isoflavones
Plasma
Human
Processing
Cross-over

Additional relevant MeSH terms:
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Cardiac Glycosides
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs