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临床试验/NCT07840248
NCT07840248尚未招募不适用

Effects of a Betaine-Supplemented Hydration Protocol on Sweat Rate and Exercise Performance in Runners

Poznan University of Life Sciences0 个研究点目标入组 20 人开始时间: 2026年10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
尚未招募
发起方
入组人数
20
主要终点
5-km Running Time-Trial Performance

研究概览

简要总结

This randomized, double-blind, placebo-controlled crossover study will investigate whether acute betaine ingestion as part of a pre-exercise hyperhydration strategy improves endurance running performance and influences hydration-related responses during prolonged exercise.

Approximately 30 recreationally trained male and premenopausal female runners will complete two experimental trials: a betaine condition and a placebo/control condition. In the betaine condition, participants will ingest anhydrous betaine at a dose of 0.07 g/kg body mass as part of a standardized pre-exercise hydration protocol providing a total fluid intake of approximately 25 mL/kg body mass.

Following the hydration protocol, participants will complete 60 minutes of treadmill running at 60% of the running velocity corresponding to VO₂max, followed by a 5-minute recovery period and a 5-km treadmill time trial.

The primary outcome will be 5-km running time-trial performance. Secondary outcomes will include exercise-induced fluid and sweat loss, urinary hydration markers, sweat electrolyte concentrations, physiological responses, exercise economy, substrate utilization, blood lactate concentration, perceived exertion, thirst, and thermal sensation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18-45 years
  • •Sex: men and premenopausal women
  • •Continuous running training for at least 12 months
  • •At least 3 running training sessions per week
  • •Willingness and ability to complete the treadmill exercise protocol: 60 minutes of running at 60% of the running velocity corresponding to VO₂max, followed by a 5-km running time trial
  • •Medical clearance for participation in maximal and prolonged exercise testing

排除标准

  • •Age <18 or >45 years
  • •Postmenopausal women
  • •Use of betaine, choline, folic acid/folate, or vitamin B12 supplements within 3 months prior to study participation
  • •Current musculoskeletal injury or injury occurring within the previous 2 months
  • •Uncontrolled arterial hypertension
  • •Pregnancy or breastfeeding
  • •Diabetes requiring insulin therapy or inadequately controlled diabetes
  • •Active or severe liver disease, including ALT or AST >3× the upper limit of normal
  • •Renal impairment, including eGFR <60 mL/min/1.73 m²
  • •Untreated or unstable thyroid disease, including hypothyroidism or hyperthyroidism
  • •Gastrointestinal disease that may affect nutrient absorption
  • •Kidney disease, cardiovascular disease, irritable bowel syndrome, or adrenal disease
  • •Use of diuretics, SGLT2 inhibitors, laxatives, or glucocorticoids
  • •Any medical contraindication to physical exercise and/or failure to obtain medical clearance for exercise testing
  • •Elevated body temperature at the time of testing
  • •Cystic fibrosis

研究组 & 干预措施

Betaine → Placebo Sequence

Experimental

Participants will first complete the betaine-enriched hyperhydration condition. After the washout period, they will complete the placebo hyperhydration condition.

干预措施: Anhydrous Betaine (Dietary Supplement)

Betaine → Placebo Sequence

Experimental

Participants will first complete the betaine-enriched hyperhydration condition. After the washout period, they will complete the placebo hyperhydration condition.

干预措施: Placebo (Other)

Placebo → Betaine Sequence

Experimental

Participants will first complete the placebo hyperhydration condition. After the washout period, they will complete the betaine-enriched hyperhydration condition.

干预措施: Anhydrous Betaine (Dietary Supplement)

Placebo → Betaine Sequence

Experimental

Participants will first complete the placebo hyperhydration condition. After the washout period, they will complete the betaine-enriched hyperhydration condition.

干预措施: Placebo (Other)

结局指标

主要结局

5-km Running Time-Trial Performance

时间窗: During the 5-km treadmill time trial performed after the 60-minute running preload and a 5-minute recovery period in each experimental trial.

Time required to complete a 5-km treadmill running time trial, expressed in seconds. Participants will be instructed to complete the distance as quickly as possible and will be allowed to adjust treadmill speed throughout the trial. Lower completion time indicates better performance.

次要结局

  • Sweat rate(From immediately before the 60-minute running preload to completion of the subsequent 5-km time trial during each experimental trial.)

研究者

发起方
Poznan University of Life Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emilia Zawieja

PhD

Poznan University of Life Sciences

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