- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05341700
Impact Loading Effect on Bone Biomarkers in Female Runners
February 28, 2024 updated by: Dawnine Enette Larson-Meyer, Virginia Polytechnic Institute and State University
The Effect of Impact Loading on Bone Biomarkers in Energy-Restricted Female Runners
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, eumenorrheic 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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Enette Larson-Meyer, PhD
- Phone Number: 540-231-1025
- Email: enette@vt.edu
Study Contact Backup
- Name: Elaina L Marinik, PhD
- Phone Number: 540-231-0923
- Email: emarinik@vt.edu
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24061
- Virginia Polytechnic Institute and State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Females runners with regular menstrual cycles, not using contraceptives
- Body Mass Index between 18.5-25.0 kg/m2
- Weight stable (+/- 2 kg) for 6 months
- Running volume of ≥30 miles per week, frequency of at least 5 days per week
- VO2max of ≥45 ml/kg/min
- Willing to consume provided meals and snacks
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endurance and Jumping Exercises
5 days of endurance treadmill running and 5 sets of 10 jumping exercises
|
Participants will complete 50-65 min running protocol on treadmill and 5 sets of 10 jumping exercises for 5 consecutive days.
Participants will also be provided all meals and snacks to induce a energy-restricted state for the 5-day period.
|
Active Comparator: Endurance Exercise Only
5 days of endurance treadmill running
|
Participants will complete only a 50-65 min running protocol on treadmill for 5 consecutive days.
Participants will also be provided all meals and snacks to induce a energy-restricted state for the 5-day period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Bone Remodeling Biomarker - N-terminal propeptide of type 1 procollagen
Time Frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
|
Levels of N-terminal propeptide of type 1 procollagen will be measured from fasted blood samples drawn before and after each 5-day intervention.
The radioimmunoassays (RIA) will be performed on all samples once the study is completed.
|
10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
|
Change in Bone Remodeling Biomarker - C-terminal telopeptide of type 1 collagen
Time Frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
|
Levels of C-terminal telopeptide of type 1 collagen will be measured from fasted blood samples drawn before and after each 5-day intervention.
The enzyme-linked immunosorbent assays (ELISA) will be performed on all samples once the study is completed.
|
10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
|
Change in Blood Metabolic Marker - Parathyroid hormone
Time Frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
|
Levels of parathyroid hormone will be measured from fasted blood samples drawn before and after each 5-day intervention.
These blood samples will be sent out to a local lab service at each timepoint.
|
10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
|
Change in Blood Metabolic Marker - Insulin-like Growth Factor-1
Time Frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
|
Levels of insulin-like growth factor-1 collagen will be measured from fasted blood samples drawn before and after each 5-day intervention.
The ELISAs will be performed on all samples once the study is completed.
|
10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
|
Change in 24-hour Glucose Patterns
Time Frame: Continuous collection for 5 consecutive days during each intervention
|
Blood glucose levels will be measured every 15 minutes during each 5-day intervention period using a continuous glucose monitor sensor secured to the arm.
The results will provide a descriptive profile of daily glucose patterns while participants are in an energy-restricted state and exercising, either only running on a treadmill daily or running on a treadmill and completing 5 sets of 10 jumping exercises daily.
|
Continuous collection for 5 consecutive days during each intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Running Economy
Time Frame: 12-minute measurement in laboratory
|
Running economy will be measured by collecting and analyzing inspired and expired air continuously during 3 4-minute progressive stages while running on a treadmill.
The last two minutes of oxygen consumption and carbon dioxide production data will be used to determine metabolic economy (ml oxygen consumed per kg body weight per minute relative to the set work performed).
Running economy will be evaluated in the laboratory at baseline and on the 5th day of each intervention period, three tests total.
|
12-minute measurement in laboratory
|
Change in Body Weight
Time Frame: 1-minute measurement in laboratory
|
Body weight will be measured on a digital scale to the closest 0.1 kg.
Body weight will be measured the day before, each of the 5 days during, and the day after each intervention.
|
1-minute measurement in laboratory
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Enette Larson-Meyer, PhD, Virginia Polytechnic Institute and State University (Virginia Tech)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2022
Primary Completion (Actual)
January 23, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
April 16, 2022
First Submitted That Met QC Criteria
April 16, 2022
First Posted (Actual)
April 22, 2022
Study Record Updates
Last Update Posted (Actual)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-168
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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