Clinical trial NCT02264223: The Bioavailability of Red Clover Isoflavones
Official title: The Effects of Processing and Matrices on Bioavailability of Red Clover Isoflavones in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Bioavailability
Isoflavones
Plasma
Human
Processing
Cross-over
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Southern Danish University
name: Herrens Mark A/S
name: Natur Drogeriet A/S
name: Future Food Innovation
First posted: 2014-10-15
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Bioavailability of isoflavones in terms of fermented vs unfermented formulations
timeFrame: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr
Secondary outcomes:
measure: Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid)
timeFrame: -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Jutland Region
Study officials:
affiliation: University of Aarhus
name: Per B Jeppesen, Prof. PhD
role: PRINCIPAL_INVESTIGATOR
References: