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Completed

NCT Number: NCT02264223

The Bioavailability of Red Clover Isoflavones

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented red clover isoflavones in aglycone form

Dietary Supplement

Fermented isoflavones in aglycone form

Unfermented glycosides (as aglycone equivalents)

Dietary Supplement

Unfermented aglycone equivalents in glycoside form

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Future Food Innovation
  • Herrens Mark A/S
  • Natur Drogeriet A/S
  • Southern Danish University

Registry information

Official study title

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

Acronym: KLBIO

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Oct 15, 2014
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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