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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endurance and Jumping Exercises | Experimental | 5 days of endurance treadmill running and 5 sets of 10 jumping exercises |
|
| Endurance Exercise Only | Active Comparator | 5 days of endurance treadmill running |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impact Load Exercises | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ferritin | Fasted serum ferritin was measured before and after each 5-day intervention period. | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enette Larson-Meyer, PhD | Virginia Polytechnic Institute and State University (Virginia Tech) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Polytechnic Institute and State University | Blacksburg | Virginia | 24061 | United States |
14 of 38 participants were randomized. Of those not randomized, 17 did not meet inclusion criteria and 7 declined to participate.
38 individuals were screened for eligibility between August 2, 2022 and October 13, 2023 in Southwest Virginia.
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| ID | Title | Description |
|---|---|---|
| FG000 | RUN, Then RUN+J | Participants first completed a 5-day period of energy restriction while running on the treadmill every day (RUN). After a washout period of at least one menstrual cycle, they then completed another 5-day period of energy restriction while running on the treadmill daily in addition to completing 5 sets of 10 jumping exercises each day (RUN+J). |
| FG001 | RUN+J, Then RUN | Participants first completed a 5-day period of energy restriction while running on the treadmill and completing 5 sets of 10 jumping exercises each day (RUN+J). After a washout period of at least one menstrual cycle, they then completed another 5-day period of energy restriction while only running on the treadmill each day (RUN). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (5 Days) |
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| Washout (One Menstrual Cycle, ~21 Days) |
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| Second Intervention (5 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RUN, Then RUN+J | Participants first completed a 5-day period of energy restriction while running on the treadmill every day (RUN). After a washout period of at least one menstrual cycle, they then completed another 5-day period of energy restriction while running on the treadmill daily in addition to completing 5 sets of 10 jumping exercises each day (RUN+J). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only participants who completed the entire intervention period were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 |
|
One week for each intervention.
Safety Population included all participants who were consuming energy-restricted diets during the intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endurance and Jumping Exercise (RUN+J) | Participants completed 5 consecutive days of exercise consisting of daily endurance treadmill running and 50 high-impact jumping exercises. The 5-day period was under a controlled energy availability condition of 15 kcal/kgFFM/day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Enette Larson-Meyer | Virginia Tech | 5402311025 | enette@vt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2023 | Jan 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000080822 | Relative Energy Deficiency in Sport |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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Randomized crossover study design
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| No Impact Load Exercises | Behavioral | 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. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| RUN+J, Then RUN |
Participants first completed a 5-day period of energy restriction while running on the treadmill and completing 5 sets of 10 jumping exercises each day (RUN+J). After a washout period of at least one menstrual cycle, they then completed another 5-day period of energy restriction while only running on the treadmill each day (RUN). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants who completed 5 days of endurance treadmill running daily without any additional impact exercise. |
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|
|
| Primary | 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. | Only participants who completed the entire intervention period were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 |
|
|
|
|
| Primary | 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. | Only participants who completed the entire intervention period were included in the analysis. | Posted | Mean | Standard Deviation | pg/mL | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 |
|
|
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|
| Primary | 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. | Only participants who completed the entire intervention period were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 |
|
|
|
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| Secondary | Change in Ferritin | Fasted serum ferritin was measured before and after each 5-day intervention period. | Only participants who completed the entire intervention period were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 |
|
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Endurance Exercise Only (RUN) | Participants completed 5 consecutive days of daily endurance treadmill running without any additional impact exercise. The 5-day period was under a controlled energy availability condition of 15 kcal/kgFFM/day. | 0 | 10 | 0 | 10 | 0 | 10 |
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