Relative Energy Deficiency in SportNCT05341700
Impact Loading Effect on Bone Biomarkers in Female Runners
A study testing Impact Load Exercises and No Impact Load Exercises in people with Relative Energy Deficiency in Sport, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Relative Energy Deficiency in Sport
- What is being tested?
- Impact Load Exercises and No Impact Load Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Relative Energy Deficiency in Sport
- Being tested
- Impact Load Exercises, No Impact Load Exercises
- Keywords
- Bone metabolism, Endurance exercise, Low energy availability, Jump training
- Medical subject headings
- Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact Load ExercisesBehavioural
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.
No Impact Load ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Endurance and Jumping Exercises | Experimental | 5 days of endurance treadmill running and 5 sets of 10 jumping exercises Receives: Behavioral: Impact Load Exercises |
| Endurance Exercise Only | Active comparator | 5 days of endurance treadmill running Receives: Behavioral: No Impact Load Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen
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.
Measured: 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 (CTX)
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.
Measured: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Change in Blood Metabolic Marker - Parathyroid Hormone
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.
Measured: 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
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.
Measured: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Secondary outcomes (1)
Change in Ferritin
Fasted serum ferritin was measured before and after each 5-day intervention period.
Measured: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start24 Aug 2022
- Primary completion23 Jan 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relative Energy Deficiency in SportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover study design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawnine Enette Larson-Meyer, Virginia Polytechnic Institute and State University
- Investigators
- Enette Larson-Meyer, PhD, Principal investigator, Virginia Polytechnic Institute and State University (Virginia Tech)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341700
- Sponsor's protocol ID
- 22-168
- Status last verified
- Aug 2025
- First submitted
- 16 Apr 2022
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Impact Loading on Bone Biomarkers in Energy-Restricted Female Runners
- ClinicalTrials.gov ID
- NCT05341700
- Acronym / sponsor ID
- 22-168
- Conditions
- Relative Energy Deficiency in Sport
- Keywords
- Bone metabolism, Endurance exercise, Low energy availability, Jump training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover study design
| Arm | Type | Receives |
|---|---|---|
| Endurance and Jumping Exercises | Experimental | Behavioral: Impact Load Exercises5 days of endurance treadmill running and 5 sets of 10 jumping exercises |
| Endurance Exercise Only | Active comparator | Behavioral: No Impact Load Exercises5 days of endurance treadmill running |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact Load ExercisesParticipants 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. | Behavioural | Endurance and Jumping Exercises |
| No Impact Load ExercisesParticipants 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. | Behavioural | Endurance Exercise Only |
Primary outcome
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
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)
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Change in Ferritin
Time frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enette Larson-Meyer, PhD principal investigator
Virginia Polytechnic Institute and State University (Virginia Tech)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact Load Exercises and No Impact Load Exercises in people with Relative Energy Deficiency in Sport, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.