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临床试验/NCT03813329
NCT03813329已完成早期 1 期

The Effects of a Novel Bicarbonate Loading Protocol on Elite Running Performance. A Randomized Placebo-controlled Trial

Long Island University0 个研究点目标入组 10 人开始时间: 2004年5月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
10
主要终点
Concentration of serum sodium bicarbonate (mmol·L-1)

研究概览

简要总结

One purpose of the present study was to evaluate the effect of elevating serum bicarbonate concentration more than had been achieved in previous studies without inducing potentially ergolytic GI distress. In order to do so, a modified SB ingestion protocol (ModSB) of 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) was administered. It was hypothesized that ModSB would significantly elevate serum bicarbonate concentration to a greater extent than would an acute SB ingestion protocol (AcuteSB).

This study was also designed to corroborate the results of previous studies regarding the ergogenic effects of sodium bicarbonate ingestion. Most studies have administered sodium bicarbonate in solutions, which would make the participants aware of the substance ingested due to the distinctive flavor of SB, possibly inducing a placebo effect. All doses in the present study were administered in gelatin capsules to mask the flavor of the ingested substances, maintaining participant blindness to the procedure.

Blood samples were collected at baseline and following placebo (CaCO3), acute sodium bicarbonate ingestion, and modified sodium bicarbonate ingestion to determine the effects of the ingestion protocols on serum bicarbonate, sodium and lactate concentrations, as well as on serum pH and blood hematocrit. The study design was a randomized double-blind crossover.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Opaque gelatin capsules

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Peak oxygen consumption greater than 60 ml·kg-1·min-1 (men) or 50 ml·kg-1·min-1 (women)
  • Currently training; defined as at least 5 days·week-1 of running
  • Elite-level performance (750 or more points on the International Associations of Athletics Federations Scoring Table) for an 800m-5000m race during the preceding 6 months.

排除标准

  • 未提供

研究组 & 干预措施

Modified Sodium Bicarbonate

Experimental

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate

干预措施: Calcium carbonate (placebo) (Dietary Supplement)

Placebo

Placebo Comparator

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate

干预措施: Calcium carbonate (placebo) (Dietary Supplement)

Acute Sodium Bicarbonate

Active Comparator

3 doses of calcium carbonate (110 mg·kg-1, 130 mg·kg-1, 160 mg·kg-1), followed by one acute does (300 mg·kg-1) of sodium bicarbonate.

干预措施: Modified Sodium Bicarbonate (Dietary Supplement)

Modified Sodium Bicarbonate

Experimental

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate

干预措施: Modified Sodium Bicarbonate (Dietary Supplement)

Acute Sodium Bicarbonate

Active Comparator

3 doses of calcium carbonate (110 mg·kg-1, 130 mg·kg-1, 160 mg·kg-1), followed by one acute does (300 mg·kg-1) of sodium bicarbonate.

干预措施: Acute Sodium Bicarbonate (Dietary Supplement)

Modified Sodium Bicarbonate

Experimental

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate

干预措施: Acute Sodium Bicarbonate (Dietary Supplement)

Placebo

Placebo Comparator

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate

干预措施: Modified Sodium Bicarbonate (Dietary Supplement)

Placebo

Placebo Comparator

4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of Calcium carbonate

干预措施: Acute Sodium Bicarbonate (Dietary Supplement)

Acute Sodium Bicarbonate

Active Comparator

3 doses of calcium carbonate (110 mg·kg-1, 130 mg·kg-1, 160 mg·kg-1), followed by one acute does (300 mg·kg-1) of sodium bicarbonate.

干预措施: Calcium carbonate (placebo) (Dietary Supplement)

结局指标

主要结局

Concentration of serum sodium bicarbonate (mmol·L-1)

时间窗: 24 hours

Blood was drawn via venipuncture and allowed to coagulate at room temperature for 25 minutes and then spun in a refrigerated centrifuge for 10 minutes. The serum was pipetted into three small vials. One vial was tested for bicarbonate concentration in duplicate with a carbon dioxide liquid stable reagent method (TR28321, Thermo Electron Corporation, Waltham, MA) using a spectrophotometer (Lambda 20, PerkinElmer, Waltham, MA).

次要结局

  • pH(24 hours)
  • Blood hematocrit (%)(24 hours)
  • Concentration of serum sodium (mmol·L-1)(24 hours)
  • Likert scale for self-reported gastrointestinal distress (1-10)(24 hours)

研究者

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

Amerigo Rossi

Assistant Professor

Long Island University

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