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临床试验/NCT06021171
NCT06021171已完成不适用

Improving the Iron Status of Athletes With Pre-, Pro- and Synbiotics

King's College2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Blood serum level of ferritin

研究概览

简要总结

Iron deficiency (ID) is the most common micronutrient deficiency worldwide, and poor iron bioavailability is a major cause. While 30% of female athletes are affected by ID, and its consequences are highly relevant to athletic performance, ID affects women and children around the world with consequences just as relevant, if not more so (e.g. school performance, work capacity and thus wage earning). With poor iron absorption being a cause of ID in active women, it is especially important to discover simple ways to improve iron (Fe) uptake. While some studies have suggested that consumption of prebiotic fiber may improve Fe absorption in animal models, there have been few studies examining the effects of synbiotic supplementation (consumption of both a prebiotic and probiotic that work together) on Fe uptake in adult females (athletes and non-athletes).

A recent pilot study demonstrated a substantial improvement in Fe uptake in female athletes after 4 and 8 weeks of synbiotic supplementation compared to placebo during Fe repletion with a low dose of ferrous sulfate (FeSO4). If synbiotic supplementation can improve the Fe bioavailability of FeSO4 (which is ~30%) in ID women during repletion of Fe status, it could possibly improve the Fe bioavailability of non-heme Fe sources, as well as mixed meals.

Research Question: What is the effect of synbiotic supplementation (a supplement containing a prebiotic + a probiotic), compared to prebiotic supplementation or a placebo, on Fe uptake and the gut microbiome in ID athletes during low-dose Fe repletion?

Hypothesis: In the proposed study, we hypothesize that synbiotic supplementation along with Fe repletion with a low dose of FeSO4 will have greatest impact on athletes' Fe uptake due to alterations in the microbiome, which will be assessed.

详细描述

The following Specific Aims will help us to answer this research question: To screen the iron status of athletes at the beginning of training season and determine the prevalence of anemia and iron depletion on our NCAA Division III campus. To determine the differences in Fe uptake with consumption of a synbiotic, prebiotic, and placebo supplements along with low-dose Fe supplementation in ID athletes. To determine the differences in the microbiome with consumption of a synbiotic, prebiotic, and placebo supplements along with low-dose Fe supplementation in ID female athletes. This aim will help us mechanism behind change in iron status with a functional fiber (e.g. synbiotic supplementation).

This data is essential to advance our understanding of how Fe uptake in active persons can be enhanced by functional fiber supplementation, as well as by REAL foods containing functional fibers, which could help ameliorate ID not only for athletes here in the US but for people around the globe.

The design is a randomized, placebo-controlled crossover trial, which will use each participant as her/his own control, in addition to a placebo treatment being administered in a counter-balanced order with the other treatments.

Participants: King's is a Division III College and currently has >85 eligible female athletes on the rosters of a variety of competitive sports teams. During a recent RCT, about 30 active women were screened and >30% were ID (1). For the proposed study, given the effect size observed in previous work (6), we need n=10 to complete the 18-week randomized crossover trial (e.g. so recruiting n=13 would allow for a "normal" 20% attrition rate during the trial due to injuries, illnesses, etc).

Iron Status Screening: Athletes from King's will be asked to volunteer via recruitment email. To address Aim 1, at baseline (and after NCAA health clearance), athletes will have their iron status screened via venous blood sample at the beginning of their season in the Human Performance Lab in the Alley Center (Complete Blood Count, which includes Hgb); Serum ferritin; C-Reactive Protein for inflammation adjustment of ferritin). Anthropometrics and body composition will be measured and health, dietary and training information will also be collected. Standard demographic information, and medical history will be self-reported by each participant using computer-based questionnaires. All athletes with normal iron status (Hgb >12.0 g/dL AND sFer>30.0 µg/L) will be given their iron status results and offered a Nutrition Consultation by a MS Nutrition Student under the supervision of the PI. Athletes will not be eligible to participate in the study if pregnant, wishing to become pregnant, breastfeeding, having a condition or taking medication impacting Fe status, or not healthy enough to train/participate in their sport.

研究设计

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

盲法说明

Volunteers will be asked to mix the powder packet (e.g. supplemental functional fiber source or placebo), with any food or beverage once daily. All 3 powders are identically packaged and only visible as white powder, and all 3 powders are colorless, odorless and tasteless when mixed in a liquid or semi-solid food. Instructions and education to both groups will be identical. Packets were sent to the Researcher pre-packaged and pre-labeled as A, B, C by the product company.

Subject randomization to treatment order was completed using random number generator by a Research Assistant not involved in direct contact with subjects.

入排标准

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

入选标准

  • 18 years of age or older
  • currently participating in or training for their sport

排除标准

  • Pregnant, or wishing to become pregnant
  • Breastfeeding
  • Having a condition or taking medication impacting iron status
  • Not healthy enough to train for/participate in their sport.

结局指标

主要结局

Blood serum level of ferritin

时间窗: baseline (0), 4, 8, 12, 16, 18 weeks

biomarker of iron status, iron stores, use to calculate Total body iron

Gut microbiome data

时间窗: baseline (0), 4, 8, 12, 16, 18 weeks

Fecal samples to yield gut bacterial taxa

Blood level of hemoglobin

时间窗: baseline (0), 4, 8, 12, 16, 18 weeks

biomarker of iron status

Blood serum level of soluble transferrin receptor

时间窗: baseline (0), 4, 8, 12, 16, 18 weeks

biomarker of iron status, tissue iron status, use to calculate Total body iron

次要结局

未报告次要终点

研究者

发起方
King's College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diane DellaValle, PhD, RDN, LDN

Associate Professor, Research Dietitian

King's College

研究点 (2)

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