The Bioavailability of Red Clover Isoflavones

Not Applicable

Completed

Interventions: Dietary Supplement: Unfermented glycosides (as aglycone equivalents)
Dietary Supplement: Fermented red clover isoflavones in aglycone form

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.

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

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

Arm && Interventions

Group	Intervention	Description
Tablet unfermented (glycoside)	Unfermented glycosides (as aglycone equivalents)	single bolus 40mg isoflavone aglycone equivalent tablet formulation of unfermented red clover isoflavones Unfermented glycosides (as aglycone equivalents)
Liquid extract (aglycone)	Fermented red clover isoflavones in aglycone form	single bolus 40mg isoflavone aglycone formulation of fermented extract in liquid Fermented red clover isoflavones in aglycone form
Yoghurt (aglycone)	Fermented red clover isoflavones in aglycone form	single bolus 40mg isoflavone aglycone formulation of fermented extract mixed with yoghurt Fermented red clover isoflavones in aglycone form
Capsule (aglycone)	Fermented red clover isoflavones in aglycone form	single bolus 40mg isoflavone formulation of fermented extract in freeze-dried capsule. Fermented red clover isoflavones in aglycone form
Tablet (aglycone)	Fermented red clover isoflavones in aglycone form	single bolus 40mg isoflavone aglycone formulation of fermented extract in freeze-dried tablet. Fermented red clover isoflavones in aglycone form

Primary Outcome Measures

Name	Time	Method
Bioavailability of isoflavones in terms of fermented vs unfermented formulations	-15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr	As measured by iAUC plasma concentrations of isoflavones over 48 hours

Secondary Outcome Measures

Name	Time	Method
Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid)	-15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr	As measured by iAUC plasma concentrations of isoflavones over 48 hours

Locations (1): Aarhus University Hospital
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Aarhus, Central Jutland Region, Denmark