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临床试验/NCT04441840
NCT04441840已完成不适用

Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise

Lindenwood University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年4月16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
75
试验地点
2
主要终点
Immune Marker

研究概览

简要总结

This study proposal seeks to examine the efficacy of probiotic supplementation at mitigating changes in immune function and recovery after completion of intense, stressful exercise while also allowing for a better understanding of its ability to promote recovery and maintenance of physical performance.

详细描述

Study Visit 1 - Familiarization:

During the familiarization visit, participants will first read and sign an IRB-approved informed consent document and complete a short form of the International Physical Activity Questionnaire (IPAQ). Participants will then have their height, weight, and body composition determined using Dual-Energy X-ray Absorptiometry (DEXA) (Hologic Discovery A). To standardize body composition assessment, participants will be required to observe an 8-hour fast and maintain a well-hydrated state. Each participant will provide a urine sample to confirm a hydrated stated through determination of a urine specific gravity values greater 1.020. Participants will then complete a peak oxygen consumption test (VO2Peak) using indirect calorimetry on a ParvoMedics TrueOne (Sandy, UT) metabolic cart interfaced to a motorized cycle ergometer (Lode Corival). The peak oxygen consumption test protocol will require each study participants to start at 100 watts before progressively increasing by 1 watt every two seconds. To determine whether maximal effort occurred a respiratory exchange ratio of >1.00 must be achieved.

Following the peak oxygen consumption assessment, participants will perform practice repetitions of all performance tests (force plate vertical jumps, isometric mid-thigh pulls, Biodex isometric and isokinetic knee extensor testing) as well as the exercises that will be performed during Visit 3 (leg press, hex bar deadlift, and drop jump).

Study Visit 2 - Pre-Supplementation Baseline Testing:

Study participants will be asked to complete a 24-hour food recall between each testing condition and will be asked to replicate their diet prior to this visit for all subsequent visits. Upon arrival, participants will first have their blood drawn from a forearm vein before completing a perceived soreness, pressure-pain threshold, and recovery assessment. Prior to testing, participants will complete the same standardized warm-up consisting of 5 minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the warm-up, participants will complete five countermovement jump squats on top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant force-time variables. Next, participants will complete two assessments of peak isometric force production. Using an electronic load cell with a 5,000-N capacity (Load Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be completed. Participants will then be outfitted on a Biodex isokinetic dynamometer where they will complete three maximal isometric knee extensions. Following the isometric knee extensor testing, participants will complete a 50-repetition test of concentric-only repetitions to assess changes in force production, torque, and rates of fatigue development. After the baseline performance testing, participants will have their leg press and hex bar deadlift one-repetition maximum (1RM) determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

盲法说明

The supplements were delivered in identical containers, each marked with a separate code marked on the outside of the supplement container. Once data collection, data entry, and statistical analysis was completely finished, the study code was broken.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Free from any disorders or diseases as stated on health history form
  • Between the ages of 18 - 55 years of age

排除标准

  • Currently being treated for or are diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2 and body fat greater than 30%), immune, autoimmune, hematological, neurological or endocrinological disorder or disease unless the scenario is viewed to not be a contraindication by the clinical coordinator of the study protocol. Individuals who are currently prescribed a hypertensive or cholesterol-lowering medication will be allowed entry into the study with clearance from clinical coordinator or their personal physician.
  • An individual who is less than 18 and greater than 55 years of age will be excluded.
  • Participants younger than 18 are excluded due to necessity of parental consent.
  • Participants greater than 55 years old lie outside of the target demographic for the current study.
  • Considered to be sedentary, defined as getting less than 30 minutes of moderate intensity physical activity for most days of the week.
  • Currently not resistance training at least 2 days per week for the past 30 days
  • Currently smoking or have quit smoking within the past 6 months
  • Currently taking a probiotic. Individuals who currently report as taking a probiotic will be allowed entry into study protocol if a wash-out period of 30 days is observed.)
  • Currently consuming any form of dietary supplements that are viewed by study investigators to confound the outcomes of the study protocol (i.e., creatine, beta-alanine, essential amino acids, beta-hydroxy-beta-methylbutyrate (HMB), branched-chain amino acids, or any pre-workout that contain combinations of these ingredients). Individuals who currently report as taking any of these supplements will be allowed entry into study protocol if a wash-out period of 30 days is observed.

结局指标

主要结局

Immune Marker

时间窗: Three weeks

Interleukin-6, Tumor necrosis factor-alpha, Monocyte chemoattractant protein 1 \[picograms per milliliter (pg/mL)\]

Complete blood count

时间窗: Three weeks

White blood cell and platelet count \[Thousand per microliter (Thousand/uL)\]

Immune Markers

时间窗: Three weeks

C-reactive protein \[milligrams per liter (mg/L)\]

Dynamic muscular fatigue

时间窗: Three weeks

Biodex 50-repetition test \[Percent fatigue rate\]

Complete blood count (CBC)

时间窗: Three weeks

Red blood cell count \[Millions per microliter (million/uL)\]

Markers of muscle damage

时间窗: Three weeks

Creatine kinase \[Units per liter (U/L)\]

Force production assessment

时间窗: Three weeks

Maximal voluntary isometric contraction (knee extension) \[pounds (lb)\]

Countermovement Jump

时间窗: Three weeks

peak force \[Newtons (N)\]

Perceived soreness

时间窗: Three weeks

Soreness questionnaire (0 - 10) 0 is low, 10 is high

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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