The Bioavailability of Red Clover Isoflavones

NCT02264223 | Completed DMC

• 1 other identifier: KLBIO 07-10-14
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioavailability; Isoflavones; Plasma; Human; Processing; Cross-over

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid)

  -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr

Study Arms (5)

Capsule (aglycone)

ACTIVE COMPARATOR

single bolus 40mg isoflavone formulation of fermented extract in freeze-dried capsule. Fermented red clover isoflavones in aglycone form

Dietary Supplement: Fermented red clover isoflavones in aglycone form

Tablet (aglycone)

ACTIVE COMPARATOR

single bolus 40mg isoflavone aglycone formulation of fermented extract in freeze-dried tablet. Fermented red clover isoflavones in aglycone form

Dietary Supplement: Fermented red clover isoflavones in aglycone form

Yoghurt (aglycone)

ACTIVE COMPARATOR

single bolus 40mg isoflavone aglycone formulation of fermented extract mixed with yoghurt Fermented red clover isoflavones in aglycone form

Dietary Supplement: Fermented red clover isoflavones in aglycone form

Liquid extract (aglycone)

ACTIVE COMPARATOR

single bolus 40mg isoflavone aglycone formulation of fermented extract in liquid Fermented red clover isoflavones in aglycone form

Dietary Supplement: Fermented red clover isoflavones in aglycone form

Tablet unfermented (glycoside)

ACTIVE COMPARATOR

single bolus 40mg isoflavone aglycone equivalent tablet formulation of unfermented red clover isoflavones Unfermented glycosides (as aglycone equivalents)

Dietary Supplement: Unfermented glycosides (as aglycone equivalents)

Interventions

Fermented red clover isoflavones in aglycone form DIETARY_SUPPLEMENT

Fermented isoflavones in aglycone form

Capsule (aglycone); Liquid extract (aglycone); Tablet (aglycone); Yoghurt (aglycone)

Unfermented glycosides (as aglycone equivalents) DIETARY_SUPPLEMENT

Unfermented aglycone equivalents in glycoside form

Tablet unfermented (glycoside)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women
• Age: 18-40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Southern Danish University: collaborator
• Herrens Mark A/S: collaborator
• Natur Drogeriet A/S: collaborator
• Future Food Innovation: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

Location

Study Officials

• Per B Jeppesen, Prof. PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof., PhD

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 15, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 23, 2022

Record last verified: 2015-12

Locations

DK (1)