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临床试验/NCT02264223
NCT02264223已完成不适用

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

University of Aarhus1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Bioavailability of isoflavones in terms of fermented vs unfermented formulations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Healthy women
  • •Age: 18-40 years

排除标准

  • •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

研究组 & 干预措施

Capsule (aglycone)

Active Comparator

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

Fermented red clover isoflavones in aglycone form

干预措施: Fermented red clover isoflavones in aglycone form (Dietary Supplement)

Tablet (aglycone)

Active Comparator

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

Fermented red clover isoflavones in aglycone form

干预措施: Fermented red clover isoflavones in aglycone form (Dietary Supplement)

Yoghurt (aglycone)

Active Comparator

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

Fermented red clover isoflavones in aglycone form

干预措施: Fermented red clover isoflavones in aglycone form (Dietary Supplement)

Liquid extract (aglycone)

Active Comparator

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

Fermented red clover isoflavones in aglycone form

干预措施: Fermented red clover isoflavones in aglycone form (Dietary Supplement)

Tablet unfermented (glycoside)

Active Comparator

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

Unfermented glycosides (as aglycone equivalents)

干预措施: Unfermented glycosides (as aglycone equivalents) (Dietary Supplement)

结局指标

主要结局

Bioavailability of isoflavones in terms of fermented vs unfermented formulations

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

As measured by iAUC plasma concentrations of isoflavones over 48 hours

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Bendix Jeppesen

Associate Prof., PhD

University of Aarhus

研究点 (1)

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