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临床试验/NCT03231514
NCT03231514已完成不适用

Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets

Texas Woman's University2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年1月最近更新:
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
59
试验地点
2
主要终点
Change in Body Composition

研究概览

简要总结

The study will examine the performance and body composition effects of ketogenic vs carbohydrate-based diets, determine the carbohydrate tolerance ("carbohydrate threshold") for active individuals on a ketogenic diet, and then, reexamine the performance and body composition effects when the diets are modified with supplemental carbohydrate up to the newly defined "ketogenic threshold."

详细描述

Participants will be recruited from TWU and the Denton area and grouped in a semi-randomized fashion that considers dietary preferences. They will then undergo baseline testing, begin the diet and training interventions, followed by post-testing (phase 1) and a carbohydrate titration period in the ketogenic diet group (phase 2). In the following academic semester, the training intervention will be repeated with an adjusted dietary carbohydrate level, delivered as a pre-workout supplement, corresponding to Phase 2 (Phase 3).

Phase 1 will consist of diets at an energy level estimated by the Mifflin St. Jeor equation adjusted by 1.625 for exercise. The exercise intervention will be a supervised, periodized (daily undulating), 9-week concurrent resistance (3 days/week) and cardiovascular (2 days/week) exercise program designed to improve body composition and performance variables. During phase 2, the ketogenic diet participants will continue exercising with the same program while consuming incrementally greater quantities of carbohydrate pre-workout until the state of ketosis is lost. Phase 3 will be identical to Phase 1, but diets will be modified to include more carbohydrate. As of completing Phase 2, this amount has been determined to be 20g of Carb10 (pea starch).

研究设计

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

盲法说明

Participants are blinded to the pre-workout drink content.

入排标准

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

入选标准

  • consistently exercising at least 3 days per week for the past 2 years, participating in both cardiovascular and resistance exercise at least once per week for the past 2 years, reported themselves as healthy, and were willing and able to comply with study protocols

排除标准

  • using tobacco of any form, a history of medical events, reporting any supplement or medication use that may affect study outcomes, regularly consuming > 7 alcoholic beverages per week, appearing unfit to handle the training program, inability to complete baseline testing, having a BMI > 35 kg/m2, or becoming < 80% compliant with training or dietary interventions.

研究组 & 干预措施

Carbohydrate Diet & Placebo & Exercise

Placebo Comparator

This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.

干预措施: Exercise (Other)

Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise

Active Comparator

This group receives the carbohydrate-based diet and supplemental carbohydrate. Will be compared to Carbohydrate & Placebo for effects of supplement. All participate in the exercise intervention.

干预措施: Carbohydrate Supplement (Carb10) (Dietary Supplement)

Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise

Active Comparator

This group receives the carbohydrate-based diet and supplemental carbohydrate. Will be compared to Carbohydrate & Placebo for effects of supplement. All participate in the exercise intervention.

干预措施: Exercise (Other)

Ketogenic Diet & Placebo & Exercise

Experimental

This group receives the ketogenic diet and flavored placebo. It is both an experimental (vs. carbohydrate diet & placebo) and placebo control group (vs. ketogenic & supplement). All participate in the exercise intervention.

干预措施: Diet (Other)

Ketogenic Diet & Placebo & Exercise

Experimental

This group receives the ketogenic diet and flavored placebo. It is both an experimental (vs. carbohydrate diet & placebo) and placebo control group (vs. ketogenic & supplement). All participate in the exercise intervention.

干预措施: Exercise (Other)

Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise

Experimental

This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.

干预措施: Carbohydrate Supplement (Carb10) (Dietary Supplement)

Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise

Experimental

This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.

干预措施: Diet (Other)

Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise

Experimental

This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.

干预措施: Exercise (Other)

结局指标

主要结局

Change in Body Composition

时间窗: 0 and 10 weeks

Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)

Change in Anaerobic Cardiovascular Performance

时间窗: 0 and 10 weeks

Will be measured as peak and average power output in Watts during a repeated Wingate sprint test

次要结局

  • Change in Body Composition(0 and 10 weeks)
  • Change in Body Water(0 and 10 weeks)
  • Change in Cross-sectional Area(0 and 10 weeks)
  • Change in Muscle Thickness(0 and 10 weeks)
  • Change in Aerobic Performance(0 and 10 weeks)
  • Change in Vertical Jump Height(0 and 10 weeks)
  • Change in Vertical Jump Power(0 and 10 weeks)
  • Change in Vertical Jump Velocity(0 and 10 weeks)
  • Change in Vertical Jump Force(0 and 10 weeks)
  • Change in Strength(0 and 10 weeks)
  • Change in Insulin(0 and 10 weeks)
  • Change in HDL(0 and 10 weeks)
  • Changes in LDL(0 and 10 weeks)
  • Changes in Triglycerides(0 and 10 weeks)
  • Changes in Aspartate Amino Transferase(0 and 10 weeks)
  • Changes in Alanine amino Transferase(0 and 10 weeks)
  • Changes in HbA1C(0 and 10 weeks)
  • Changes in Creatine Kinase(0 and 10 weeks)
  • Changes in Total Testosterone(0 and 10 weeks)
  • Changes in Total Estrogens(0 and 10 weeks)
  • Changes in Triiodothyronine(0 and 10 weeks)
  • Changes in Thyroxine(0 and 10 weeks)
  • Changes in Thyroid Stimulating Hormone(0 and 10 weeks)
  • changes in C-reactive Protein(0 and 10 weeks)
  • Changes in Dehydroepiandrosterone sulfate(0 and 10 weeks)
  • Changes in Sex hormone Binding Globulin(0 and 10 weeks)
  • Changes in Cortisol(0 and 10 weeks)
  • Changes in Whole Blood Betahydroxybutyrate(about every 3-7 days)
  • Changes in Free Testosterone(0 and 10 weeks)

研究者

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

Jordan Joy

Principal Investigator

Texas Woman's University

研究点 (2)

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