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临床试验/NCT06648967
NCT06648967已完成不适用

Hydrogen Breath Test Results After Consuming Fructose at Baseline and After Protein Supplementation

Arizona State University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年10月3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
发起方
入组人数
8
试验地点
1
主要终点
Hydrogen breath curve

研究概览

简要总结

GI distress is widely prevalent among athletes, ranging from 30 to 90% in recreationally and professionally active athletes. As the recipient of nutrients, the gastrointestinal (GI) tract plays an important role in athleticism. The following pilot project aims to better understand if a fructose load after hiking under heat stress will result in a meaningful hydrogen breath elevation as a marker for malabsorption in healthy participants, and if supplementation of a multi-ingredient fermented whey supplement will result in a different hydrogen breath response rate after a heat stress hiking test.

详细描述

The present study aims to examine the difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve, as well as taking multiple self-reported gastrointestinal symptom ratings.

In addition, the study aims to evaluate the difference in hydrogen breath response and gastrointestinal symptom ratings (using one of the previously determined carbohydrate boluses) after supplementing a multi-ingredient whey protein for 3 weeks, followed by 2 more weeks of supplementation.

The objective of the study is to answer following questions:

Question 1: Does treadmill hiking in the heat combined with a glucose-fructose feeding (i.e. ration 2:1 or 1:2) result in different hydrogen breath malabsorption curves and GI symptoms.

Question 2: Is there a difference in hydrogen breath test curves and self-reported gastrointestinal symptom ratings over time, after 3 and 5 weeks of supplementation, when consuming a multi-ingredient whey supplement compared to baseline.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy subjects living in the United States.
  • •Women/Men aged between 18-60 years (50-50%).
  • •BMI value between ≥18.5 and ≤ 30 kg/m
  • •No physical limitations (i.e., able to perform all activities associated with daily living in an independent manner).
  • •Written informed consent.
  • •Completed PAR-Q+ without any "yes" responses.
  • •If currently using chronically or intermittently, willing to stop taking pre- and probiotics beginning 1 month prior to and throughout data collection.
  • •If currently using chronically or intermittently, willing to stop using laxatives or fiber supplements, antacids and prokinetics beginning 1 month prior to and throughout data collection.

排除标准

  • •Clinical or self-perceived lactose intolerance.
  • •Clinical or self-perceived milk protein allergy.
  • •Diagnosed GI tract disorders or diseases.
  • •Musculoskeletal disorders.
  • •Diagnosed metabolic disorders (such as diabetes).
  • •Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
  • •Chronic use of gastric acid suppressing medication or anti-coagulants.
  • •Chronic use of anti-inflammatory medication.
  • •Unwilling to stop taking pre- and probiotics beginning 1 month prior to and throughout data collection.
  • •Unwilling to stop using laxatives or fiber supplements, antacids and prokinetics beginning 1 month prior to and throughout data collection.

研究组 & 干预措施

Baseline exercise tests with carbohydrate feeding and after supplementation

Experimental

This arms includes the assessment for difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve, as well as taking multiple self-reported gastrointestinal symptom ratings during exercise test 1 and 2. In addition, this arm will assess hydrogen breath response and gastrointestinal symptom ratings (using one of the previously determined carbohydrate boluses) after supplementing a multi-ingredient whey protein for 3 weeks, followed by 2 more weeks of supplementation.

干预措施: Supplementation with a multi-ingredient whey supplement (Dietary Supplement)

结局指标

主要结局

Hydrogen breath curve

时间窗: Measurements will be taken at -65 min before exercise, directly after exercise at 0 min, and at 30/120/150 and 180 min).

Fructose malabsorption will be determined by creating a hydrogen breath curve for each test day.

次要结局

  • Gastrointestinal symptoms(Adjusted GSRS (for a 60 min period) will be used to obtain self-reported gastrointestinal distress at -65 min (before exercise), 0 min (directly after exercise), and at 60/120 and 180 min.)

研究者

发起方
Arizona State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Floris Wardenaar

Assistant Professor

Arizona State University

研究点 (1)

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