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临床试验/NCT03176212
NCT03176212已完成不适用

Effect of Milk Fat Globule Membrane (MFGM) on Gut Barrier Protection in Runners

Utah State University0 个研究点目标入组 14 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
主要终点
Change in gut permeability via differential sugar test

研究概览

简要总结

This study was designed to determine if an ingredient in milk fat can prevent gut leakiness induced by running at 80% maximum oxygen consumption (VO2max). In mouse studies, the milk fat ingredient, and individual components thereof, have been shown to reduce gut leakiness induced by intra peritoneal lipopolysaccharide (LPS) injections.

The investigators hypothesis is as follows: Compared to a sports drink with identical macro nutrient composition, a sports drink with milk fat globule membrane (MFGM) will reduce the change in gut leakiness induced by running at 90% VO2max for 30 minutes. The decrease in gut permeability change will be associated with a decreased area under the curve of plasma endotoxin for 5 hours following the exercise. In addition, decreased gut permeability will be associated with lower area under the curve values for inflammatory cytokines.

详细描述

A randomized, double-blind cross-over exercise trial was conducted with 14 runners on Utah State University campus. This population of 14 runners was selected from a larger population of 20 that was recruited to complete two initial trials. In two preliminary visits, the parameters necessary for conducting the experimental trial were determined. During the first visit, a baseline value was determined for gut permeability as well as aerobic capacity of runners. In the second visit the capacity to complete a run at 80% VO2max was tested and the effect of the exercise stress on gut permeability, plasma LPS and core temperature were measured.

Once a test population was selected, a randomized, double-blind, cross-over trial was conducted in which MFGM was tested for the ability to prevent a change in the exercise induced gut permeability.

During each testing session heart rate (HR), work output and core temperature (CT) were monitored. HR and CT were monitored by a CorTemp™ temperature pill which was ingested by the athletes prior to the trial (http://www.hqinc.net/pages/pill_page.html). In addition, blood was drawn at baseline (before depletion trial), immediately after the time trial, and again at 1h and 5h. Blood was analyzed for indices of training intensity (lactate), muscle damage (creatine kinase, cytokines), and gut barrier dysfunction (lipopolysaccharide, cytokines). In addition, immediately after the run athletes consumed a beverage with two carbohydrates (lactulose, and rhamnose). During the following six hours urine was collected and these sugars were measured via gas chromatography to determine the permeability of the gut.

Subject Recruitment Twenty, runners (ages 18-50) were initially recruited via campus flyers, advertisements in the local paper and weekly sports guide. Participants who had medical histories including: heart disease, uncontrolled hypertension, diabetes, Crohn's Disease, irritable bowel syndrome, colitis, Celiac disease, inflammatory or autoimmune diseases or lactose intolerance were excluded from the study. All subjects were instructed to avoid all anti-inflammatory medications for at least 24 h prior to any testing activity. On the morning of the first visit, approved subjects had body composition measured by BodPod (Life Measurement, Inc., Concord, CA). Participants were asked to refrain from any heavy exercise for 48 hrs before the first visit. Subjects were given a 50 ml tube containing the 5 g lactulose and 2 g rhamnose sugar probe and instructed to drink the probe 4hrs after they have finished breakfast to determine baseline gut permeability. Subjects were given a urine collection container and instructed to collect all urine for 6 hrs after ingestion of the probe. Subjects were not to eat lunch until 1.5 hrs after drinking the sugar probe. After 6 hrs of urine collection, subjects returned to the test site and performed a running VO2 max test.

Second Visit (approximately one week after first visit) Approximately 3 hrs after completion of breakfast, subjects reported to the test site to have blood drawn (to determine baseline plasma LPS), weight measured and to ingest a temperature probe. Participants started the exercise challenge (60 minute run at 80% VO2 max) approximately 4 hrs after completion of breakfast. The exercise challenge was conducted in a climate-controlled room at 22 °C without a fan. Subjects were monitored to ensure they were running at 80% VO2 max and were not allowed to consume water during the challenge. Immediately after the exercise challenge, participants consumed the sugar probes. Weight was measured, blood drawn (post-exercise plasma LPS) and subjects were instructed to collect their urine for the next six hrs. To facilitate re hydration and urine production, subjects were instructed to replace 150% of their fluid losses (pre to post exercise weight) by water intake.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to run at 80%V02max for 30m, availability to complete the study.

排除标准

  • Heart disease, uncontrolled hypertension, diabetes, Crohn's Disease, irritable bowel syndrome, colitis, celiac disease, inflammatory or autoimmune diseases, and lactose intolerance.

结局指标

主要结局

Change in gut permeability via differential sugar test

时间窗: Gut permeability was measured three times in this study. Once at baseline, and twice after the exercise challenges. The total time to complete the assessment was approximately 3 weeks.

In this outcome, the barrier properties of the gut are assessed indirectly. Subjects consume a mixture of lactulose and mannitol. Mannitol is a monosaccharide and is passively absorbed from the gut and eliminated via the urine. Lactulose, on the other hand, is an indigestible disaccharide. If it appears in the urine, it is thought to pass into the body through loose tight junctions between the mouth and large intestine. If it reaches the large intestine, lactulose will be fermented by the microbiome. Subjects consume the sugar mixture and urine is collected for 6 hours. In this study, gut permeability was measured at baseline, and after after the running tests.

次要结局

  • Change in plasma cytokines(This outcome was measured twice in a time frame of less than three weeks.)
  • Core temperature increase(This outcome was measured twice in a time frame of less than three weeks.)
  • Change in plasma lactate(This outcome was measured twice in a time frame of less than three weeks.)
  • Change in plasma endotoxin(This outcome was measured twice in a time frame of less than three weeks.)
  • Change in plasma creatine kinase(This outcome was measured twice in a time frame of less than three weeks.)

研究者

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

Robert Ward

Associate Professor

Utah State University

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