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临床试验/NCT04821076
NCT04821076已完成不适用

Influence of Low Energy Availability on Performance and Health in Trained and Recreationally Active Women

University of Aarhus2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月1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
30
试验地点
2
主要终点
Changes in muscle protein synthesis

研究概览

简要总结

The project is designed as a randomized controlled intervention trial in which 60 young trained (n = 30) (Population A) and recreationally active (n = 30) women (Population B) with regular menstruation are divided into four groups. Population A will receive a low-calorie diet + exercise or an energy balanced diet + exercise over 10 days. Population B will receive a low-calorie diet without exercise, or an energy balanced diet over 10 days. The participants are matched in pairs based on training history and randomized. Before the diet period, the groups will undergo a 6-day control period, during which all participants must take an energy-balanced diet (± training). After the 10 days of the diet intervention period, the groups will receive an energy-balanced diet for 2 days. Before, during, and after the trial period, participants will perform performance tests. In addition, 3 muscle biopsies, 2 adipose biopsies, blood samples, urine samples will be taken during the period, as well as resting metabolic rate, electrocardiogram, flow-mediated vasodilation, and body composition over the trial period. Muscle protein synthesis rate will be measured over the period using stable isotope technique, which includes ingestion of heavy water (D2O) and collection of saliva samples daily (days 0 to 16). The primary measurement parameter is changes in muscle protein synthesis rate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • age 18-30
  • BMI 18.5-30
  • Regular training at least 4 times a week and a maximum of 10 times a week (≥1 times strength training, ≥1 times endurance training / interval training or interval-based sports

排除标准

  • • Irregular menstruation within the last 6 months (shorter end 24 days or longer end 35 days cycle)
  • Used hormonal contraception within the last 3 months for the trial.
  • Injuries / pain in the lower body, which prevents participation in intense strength training
  • Medication consumption that may affect protein metabolism and inflammatory parameters.
  • Unstable weight / major weight loss (weight fluctuations of more than 5 kg in the last six months)
  • Do not eat animal products
  • Eating disorder
  • Pregnancy
  • Blood donor within the last month
  • Cannot read or understand Danish

结局指标

主要结局

Changes in muscle protein synthesis

时间窗: 10 days of diet+exercise intervention

次要结局

  • Cortisol Levels(During the course of the whole intervention period (18 days))
  • Sarcoplasmic reticulum function(before and after 10 days of diet+exercise intervention)
  • Maximal isometric and dynamic muscle strength(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • Repeated sprint ability(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • Markers of muscle protein synthesis and breakdown(before and after 10 days of diet+exercise intervention)
  • Macrophage content in adipose tissue(before and after 10 days of diet+exercise intervention)
  • Muscle glycogen and lipid levels(before and after 10 days of diet+exercise intervention)
  • Adipocyte area and cell size in adipose tissue(before and after 10 days of diet+exercise intervention)
  • Expression of fat oxidative proteins in adipose tissue(before and after 10 days of diet+exercise intervention)
  • Maximal vertical jump height(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • 4-minute time trial performance(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • Sex hormone levels(During the course of the whole intervention period (18 days))
  • Inflammatory levels(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • Bone turnover levels(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • Electrocardiogram - Qt interval(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • Flow mediated vasodilation(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • Resting metabolic rate(before and after 10 days of diet+exercise intervention and 2 days of energybalance)
  • Body composition(before and after 10 days of diet+exercise intervention and 2 days of energybalance)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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