The Bioavailability of Red Clover Isoflavones — KLBIO  

Healthy Clinical Trial

Official title: The Effects of Processing and Matrices on Bioavailability of Red Clover Isoflavones in Healthy Women

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT02264223
• Study type: Interventional
• Source: University of Aarhus
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Completion date: May 2022