Overview

This trial is active, not recruiting.

Condition healthy
Treatments fermented red clover isoflavones in aglycone form, unfermented glycosides (as aglycone equivalents)
Sponsor University of Aarhus
Collaborator Southern Danish University
Start date October 2014
End date October 2016
Trial size 16 participants
Trial identifier NCT02264223, KLBIO 07-10-14

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
single bolus 40mg isoflavone formulation of fermented extract in freeze-dried capsule. Fermented red clover isoflavones in aglycone form
fermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form
(Active Comparator)
single bolus 40mg isoflavone aglycone formulation of fermented extract in freeze-dried tablet. Fermented red clover isoflavones in aglycone form
fermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form
(Active Comparator)
single bolus 40mg isoflavone aglycone formulation of fermented extract mixed with yoghurt Fermented red clover isoflavones in aglycone form
fermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form
(Active Comparator)
single bolus 40mg isoflavone aglycone formulation of fermented extract in liquid Fermented red clover isoflavones in aglycone form
fermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form
(Active Comparator)
single bolus 40mg isoflavone aglycone equivalent tablet formulation of unfermented red clover isoflavones Unfermented glycosides (as aglycone equivalents)
unfermented glycosides (as aglycone equivalents)
Unfermented aglycone equivalents in glycoside form

Primary Outcomes

Measure
Bioavailability of isoflavones in terms of fermented vs unfermented formulations
time frame: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr

Secondary Outcomes

Measure
Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid)
time frame: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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

Additional Information

Official title The Effects of Processing and Matrices on Bioavailability of Red Clover Isoflavones in Healthy Women
Principal investigator Per B Jeppesen, Prof. PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Aarhus.