跳至主要内容
临床试验/NCT03030716
NCT03030716已完成不适用

Long-term, Multiple Daily Condensed Tannin Supplementation in Increasing Concentrations Does Not Affect Iron Status or Bioavailability: Results From the Tannin-dose Response Trial.

Kansas State University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2016年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Change in baseline to endline area under the curve after meal challenge at weeks 0 and 4 of each intervention

研究概览

简要总结

Tannins are known to inhibit iron absorption through formation of insoluble tannin-mineral complexes, and have thus been termed 'antinutritional.' Despite this, there is evidence that adaptation to similar antinutritional factors is possible when consumed over time. Limitations in current studies include short (single meal) duration, and use of incongruent tannin types from the condensed tannins that are commonly consumed. If adaptation to tannins does happen, it may be due to salivary proline-rich proteins, which have been found to be protective of iron status in animal models. The primary objectives of this study are: 1) To determine whether condensed tannins impact iron bioavailability or status when consumed in multi-dose, multiple daily supplements and 2) to test whether salivary protein production may impact iron bioavailability with tannin supplementation. Secondary objectives included assessment of the reliability of astringency as a measure of salivary protein production and iron absorption.

The study has been conducted in an iron absorption study of 11 women, aged 18-35 years old, to determine iron bioavailability with supplementation of 0.03, 0.25, and 1.5 g 95% proanthocyanidin rich grape seed extract before and after regular, three times daily supplementation for four weeks. Each participant consumed all three concentrations of supplement over the 26-week study, with a two-week washout between interventions. Direct iron absorption was measured using area under the curve. Iron status was measured by changes in hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were collected before and after supplement consumption during meal challenges, and analyzed on HPLC. Astringency testing was conducted at the end of each meal challenge. Iron absorption and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise comparison by least significant differences. Pearson's correlations were used to correlated salivary proteins and astringency with iron bioavailability.

The present study will provide important information regarding the approximate influence of condensed tannin consumption on iron bioavailability and storage over time, at different doses. Data will also help to delineate possible physiological mechanisms underlying tannin adaptation and possible ways to detect individuals who better adapt than others.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, 18-35 years old
  • Non-obese BMI (18-29.9)
  • Signed informed consent

排除标准

  • Oral disease
  • Gastrointestinal disease
  • Tobacco user
  • Heavy alcohol user
  • Pregnancy (assessed by pregnancy test)
  • Lactation
  • Medications affecting iron bioavailability
  • Vitamin or mineral supplementation (other than vitamin B12)

结局指标

主要结局

Change in baseline to endline area under the curve after meal challenge at weeks 0 and 4 of each intervention

时间窗: Baseline and 4 weeks

Change in area under the curve will be measured after administration of test meal including ferrous sulfate and condensed tannin supplementation at weeks 0 and 4

Change in salivary proteins at weeks 0 and 4 of each intervention

时间窗: Baseline and 4 weeks

HPLC determination of salivary proteins will be analyzed from saliva collected before and after test meals at weeks 0 and 4 of each intervention

Change in baseline to endline hemoglobin and serum ferritin at weeks 0 and 4 of each intervention

时间窗: Baseline and 4 weeks

Change in ferritin and hemoglobin will be measured before administration of test meals at weeks 0 and 4

次要结局

未报告次要终点

研究者

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

Brian Lindshield

Ph.D., Associate Professor

Kansas State University

研究点 (2)

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