Healthy
Conditions
Keywords
Bioavailability, Isoflavones, Plasma, Human, Processing, Cross-over
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.
Interventions
DIETARY_SUPPLEMENTFermented red clover isoflavones in aglycone form
Fermented isoflavones in aglycone form
DIETARY_SUPPLEMENTUnfermented glycosides (as aglycone equivalents)
Unfermented aglycone equivalents in glycoside form
Sponsors
Southern Danish University
Herrens Mark A/S
Natur Drogeriet A/S
Future Food Innovation
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioavailability of isoflavones in terms of fermented vs unfermented formulations | -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr | As measured by iAUC plasma concentrations of isoflavones over 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioavailability of isoflavones in terms of matrices (tablet, capsule, yoghurt and liquid) | -15min, 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 24hr, 48hr | As measured by iAUC plasma concentrations of isoflavones over 48 hours |
Countries
Denmark
Outcome results
None listed