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临床试验/NCT05341700
NCT05341700已完成不适用

The Effect of Impact Loading on Bone Biomarkers in Energy-Restricted Female Runners

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年8月24日最近更新:
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
14
试验地点
1
主要终点
Change in Blood Metabolic Marker - Insulin-like Growth Factor-1

研究概览

简要总结

This study is a randomized, cross-over intervention study that will evaluate the effect of brief, high-impact loading exercises on biomarkers of bone metabolism in energy-restricted female runners. Volunteers will complete two 5-day experimental conditions in a randomized order separated by one menstrual cycle (approximately 3 weeks). Experimental conditions will include a dietary intervention of energy intake equal to 30 kcal/kg of fat-free mass/d using controlled diets and an exercise intervention of daily treadmill running with or without an additional 50 impact loading exercises.

详细描述

Many long-distance runners struggle to consume enough calories each day to match the number of calories they are burning during exercise and as part of daily living. Undereating for long periods of time is a serious concern because it can have negative effects on general health and sports performance. One of these long-term consequences is related to bone health. With undereating, bone can start to be broken down faster than it can be rebuilt. Even though it can take months, and even years, for bone to be seriously affected, this may lead to weak and brittle bones later in life, if it is left untreated. Typically, athletes are recommended to increase the number of calories they eat to prevent negative health concerns. However, not all athletes may be willing or able to increase their calories based on their performance goals, nutrition knowledge, or concerns with food security. This means that alternative strategies need to be investigated to counteract the negative effects of undereating on bone health. This study proposes to evaluate the effect of adding short bouts of high-impact jumping exercises to typical endurance training to promote healthy bone metabolism. This will specifically involve completing two phases of a supervised treadmill run and consuming a reduced-calorie diet (provided by the research team) on 5 consecutive days. In addition, one of the phases will include performing 5 sets of 10 jumping exercises on 5 consecutive days in addition to the treadmill run. Results of the study will serve as an important first step in helping exercise and medical professionals understand more about how to protect and manage the bone health of female long-distance runners.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Females runners with regular menstrual cycles, not using contraceptives
  • •Body Mass Index between 18.5-30.0 kg/m2
  • •Weight stable (+/- 2 kg) for 6 months
  • •VO2max of ≥35 ml/kg/min
  • •Willing to consume provided meals and snacks

排除标准

  • •Low Energy Availability in Females Questionnaire (LEAF-Q) score ≥8
  • •Menstrual disturbances measured by progesterone and self-report
  • •Using contraceptives (oral contraceptives, injections, intrauterine device, etc.)
  • •Low Bone Mineral Density (z-score < -1)
  • •Routine engagement in mechanical loading exercises
  • •History of fracture in the previous 6 months
  • •Recent recovery (within the last 12 months) or still in recovery after eating disorder diagnosis
  • •Medication use that could affect bone metabolism (e.g., corticosteroids, anticonvulsants, heparin, gonadotropin-releasing hormone agonists)
  • •Pregnancy or lactation
  • •Abnormal thyroid-stimulating hormone levels

研究组 & 干预措施

Endurance and Jumping Exercises

Experimental

5 days of endurance treadmill running and 5 sets of 10 jumping exercises

干预措施: Impact Load Exercises (Behavioral)

Endurance Exercise Only

Active Comparator

5 days of endurance treadmill running

干预措施: No Impact Load Exercises (Behavioral)

结局指标

主要结局

Change in Blood Metabolic Marker - Insulin-like Growth Factor-1

时间窗: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6

Insulin-like growth factor-1 (IGF1) concentration was measured from fasted blood samples collected before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.

Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen

时间窗: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6

Plasma N-terminal propeptide of type 1 procollagen (PINP) was collected from fasted blood samples drawn before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.

Change in Bone Remodeling Biomarker - C-terminal Telopeptide of Type 1 Collagen (CTX)

时间窗: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6

Serum C-terminal telopeptide of type 1 collagen (CTX) was collected from fasted blood samples drawn before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.

Change in Blood Metabolic Marker - Parathyroid Hormone

时间窗: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6

Parathyroid hormone levels were measured from fasted blood samples collected before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.

Change in Blood Metabolic Marker - Insulin-like Growth Factor-1

时间窗: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6

Insulin-like growth factor-1 (IGF1) concentration was measured from fasted blood samples collected before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.

次要结局

  • Change in Ferritin(10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6)

研究者

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

Dawnine Enette Larson-Meyer

Professor

Virginia Polytechnic Institute and State University

研究点 (1)

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