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Clinical Trials/NCT02264223
NCT02264223CompletedNot Applicable

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

University of Aarhus2 sites in 1 country16 target enrollmentStarted: October 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
2
Primary Endpoint
Bioavailability of isoflavones in terms of fermented vs unfermented formulations

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

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

  • Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid)(-15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Per Bendix Jeppesen

Associate Prof., PhD

University of Aarhus

Study Sites (2)

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