The Bioavailability of Red Clover Isoflavones

NCT ID: NCT02264223

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2022-05-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Capsule (aglycone)

single bolus 40mg isoflavone formulation of fermented extract in freeze-dried capsule.

Fermented red clover isoflavones in aglycone form

Group Type: ACTIVE_COMPARATOR

Fermented red clover isoflavones in aglycone form

Intervention Type: DIETARY_SUPPLEMENT

Fermented isoflavones in aglycone form

Tablet (aglycone)

single bolus 40mg isoflavone aglycone formulation of fermented extract in freeze-dried tablet.

Fermented red clover isoflavones in aglycone form

Group Type: ACTIVE_COMPARATOR

Fermented red clover isoflavones in aglycone form

Intervention Type: DIETARY_SUPPLEMENT

Fermented isoflavones in aglycone form

Yoghurt (aglycone)

single bolus 40mg isoflavone aglycone formulation of fermented extract mixed with yoghurt

Fermented red clover isoflavones in aglycone form

Group Type: ACTIVE_COMPARATOR

Fermented red clover isoflavones in aglycone form

Intervention Type: DIETARY_SUPPLEMENT

Fermented isoflavones in aglycone form

Liquid extract (aglycone)

single bolus 40mg isoflavone aglycone formulation of fermented extract in liquid

Fermented red clover isoflavones in aglycone form

Group Type: ACTIVE_COMPARATOR

Fermented red clover isoflavones in aglycone form

Intervention Type: DIETARY_SUPPLEMENT

Fermented isoflavones in aglycone form

Tablet unfermented (glycoside)

single bolus 40mg isoflavone aglycone equivalent tablet formulation of unfermented red clover isoflavones

Unfermented glycosides (as aglycone equivalents)

Group Type: ACTIVE_COMPARATOR

Unfermented glycosides (as aglycone equivalents)

Intervention Type: DIETARY_SUPPLEMENT

Unfermented aglycone equivalents in glycoside form

Interventions

Fermented red clover isoflavones in aglycone form

Fermented isoflavones in aglycone form

Intervention Type: DIETARY_SUPPLEMENT

Unfermented glycosides (as aglycone equivalents)

Unfermented aglycone equivalents in glycoside form

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Southern Danish University

UNKNOWN

Sponsor Role: collaborator

Herrens Mark A/S

UNKNOWN

Sponsor Role: collaborator

Natur Drogeriet A/S

UNKNOWN

Sponsor Role: collaborator

Future Food Innovation

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Per Bendix Jeppesen

Associate Prof., PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per B Jeppesen, Prof. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Countries

Denmark

Other Identifiers

KLBIO 07-10-14

Identifier Type: -

Identifier Source: org_study_id