The Bioavailability of Red Clover Isoflavones

Healthy Clinical Trial

— KLBIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264223
• Other study ID #: KLBIO 07-10-14
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 2022

Study information

• Verified date: December 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Jutland Region

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Future Food Innovation, Herrens Mark A/S, Natur Drogeriet A/S, Southern Danish University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of isoflavones in terms of fermented vs unfermented formulations	As measured by iAUC plasma concentrations of isoflavones over 48 hours	-15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr
Secondary	Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid)	As measured by iAUC plasma concentrations of isoflavones over 48 hours	-15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr