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临床试验/NCT02762968
NCT02762968已完成不适用

The Effects of 8-weeks of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers

Metabolic Technologies Inc.1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年4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
26
试验地点
1
主要终点
Maintenance of Immune function

研究概览

简要总结

The study will determine whether acute ingestion of a probiotic combined with beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers during 8-weeks of advanced infantry training.

详细描述

Up to sixty soldiers from an elite infantry unit will perform a parallel design investigation. Soldiers will be randomly assigned to one of four groups. Group 1 will consume the probiotic plus HMB, group 2 will consume HMB only, group 3 will consume only the probiotic, and group 4 will consume only placebo. All four groups will be garrisoned together, eat the same meals, and perform the same activity. All groups will be tested before as well as after an 8-week advanced infantry training program. During each testing session resting blood samples will be obtained to assess cytokine, inflammatory, and muscle damage markers. Additionally, questionnaires will be used to determine digestive health. Anthropometric, performance, and muscle volume measures will also be assessed prior to and immediately following the supplementation and training protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18 years of age
  • •Member of the same unit of the IDF

排除标准

  • •Current use of dietary supplements
  • •Current chronic use of medications

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo capsules similar to the experimental treatments.

干预措施: Placebo (Dietary Supplement)

HMB

Experimental

HMB capsules providing 3 g of calcium HMB per day.

干预措施: HMB (Dietary Supplement)

HMB + BC30

Experimental

Capsules providing 3 g calcium HMB per day plus Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.

干预措施: HMB (Dietary Supplement)

HMB + BC30

Experimental

Capsules providing 3 g calcium HMB per day plus Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.

干预措施: BC30 (Dietary Supplement)

结局指标

主要结局

Maintenance of Immune function

时间窗: 8 weeks

Immune function assessed by blood biochemical analysis (ELISA).

次要结局

  • Maintenance of Digestive Function(8 Weeks)
  • Maintenance of Muscle Volume(8 Weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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