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临床试验/NCT07224282
NCT07224282尚未招募1 期

The Effects of R-1,3-Butanediol With Carbohydrate Supplementation on Cycling Performance Above Lactate Threshold

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年11月17日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
15
试验地点
2
主要终点
Time to fatigue

研究概览

简要总结

The goal of this clinical trial is to determine whether a ketone supplement with carbohydrates extends time to fatigue during cycling compared with a carbohydrate-only supplement in healthy, trained cyclists aged 18-55. The main questions it aims to answer are:

Is the time to fatigue increased with ketone supplementation and carbohydrates compared to carbohydrates alone? Will ketone supplementation with carbohydrates produce lower blood lactate concentrations compared to carbohydrates alone?

Participants will:

  • Perform a staged maximal cycling exercise test on a stationary bicycle.
  • Finger prick to obtain a drop of blood for lactate measurements.
  • Wear a mask connected to a metabolic cart to measure breath contents.
  • Perform a cycling exercise test to fatigue for at least one hour.
  • Consume either a ketone supplement with carbohydrates or a carbohydrate supplement during the exercise at least 4 times.
  • Finger prick to obtain a drop of blood to measure blood lactate, ketones, and glucose.

详细描述

The significance of this study is to address gaps in the literature by investigating the combined effects of R-1,3-Butanediol and carbohydrate supplementation on cycling performance during steady-state exercise above the lactate threshold. Participants include:

  1. Trained cyclists ages 18-55

  2. ≥ 6 hours of cycle training per week.

  3. Above average VO2max for their age range per ACSM guidelines.

  4. The sample is drawn from the University of Oklahoma, local cycling events in Oklahoma, and local bicycle shops.

There will be a total of three visits, lasting approximately one hour and separated by at least 7 days. The protocol begins with a familiarization visit, during which participants complete a maximal graded exercise test. They are instructed to be at least 4 hours postabsorptive and not complete strenuous exercise within 24 hours of the initial visit, and each participant signs an informed consent form, fills out a POMS questionnaire, and exercise history questionnaire (PAR-Q). Participants' height and weight were recorded, and their bicycles will be connected to the cycling trainer or will use the Zwift One stationary bicycle. To determine VO2 max and lactate threshold, a continuous incremental cycling test will be performed. The test begins at 1 watt per kilogram of body weight and increases 0.5 watts per kilogram of body weight every 3 minutes until two of the following were reached: volitional fatigue, inability to maintain cadence within 10 rpm of their preferred cadence, maximal heart rate within 10 bpm of age-predicted max heart rate, or respiratory exchange ratio greater than 1.10 The intent is to provide insights into metabolic and performance responses beyond traditional exercise intensities. The findings could inform endurance athletes and coaches on nutritional strategies for sustaining performance during high-intensity efforts.The study aims to investigate the performance effects of a ketone supplement (R-1,3-Butanediol) with carbohydrate supplementation on cycling performance above the lactate threshold. It aims to determine whether time to fatigue will be affected and if blood lactate concentrations will decrease due to ketone supplementation. Hypotheses include:

Time to fatigue is increased with ketone supplementation and carbohydrates compared to carbohydrates alone.

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
None

入排标准

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

入选标准

  • Highly trained males and females
  • Ages 18-55
  • Greater than or equal to six hours of cycling training per week
  • Participants from the University of Oklahoma, Oklahoma cycling teams, and local cycling races in Oklahoma.

排除标准

  • Cardiovascular disease
  • Respiratory disease
  • Gastrointestinal disease
  • Metabolic disease
  • Kidney disease
  • Neurological disease
  • Pregnancy

结局指标

主要结局

Time to fatigue

时间窗: Through study completion, an average of 2 weeks.

次要结局

  • Blood lactate(Through study completion, an average of 2 weeks.)
  • Blood Glucose(Through study completion, an average of 2 weeks.)
  • Beta-hydroxybutyrate levels(Through study completion, an average of 2 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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