Trial Outcomes & Findings for Impact Loading Effect on Bone Biomarkers in Female Runners (NCT NCT05341700)
NCT ID: NCT05341700
Last Updated: 2025-08-19
Results Overview
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.
COMPLETED
NA
14 participants
10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
2025-08-19
Participant Flow
38 individuals were screened for eligibility between August 2, 2022 and October 13, 2023 in Southwest Virginia.
14 of 38 participants were randomized. Of those not randomized, 17 did not meet inclusion criteria and 7 declined to participate.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
First Intervention (5 Days)
STARTED
|
7
|
7
|
|
First Intervention (5 Days)
COMPLETED
|
6
|
7
|
|
First Intervention (5 Days)
NOT COMPLETED
|
1
|
0
|
|
Washout (One Menstrual Cycle, ~21 Days)
STARTED
|
6
|
7
|
|
Washout (One Menstrual Cycle, ~21 Days)
COMPLETED
|
6
|
5
|
|
Washout (One Menstrual Cycle, ~21 Days)
NOT COMPLETED
|
0
|
2
|
|
Second Intervention (5 Days)
STARTED
|
6
|
5
|
|
Second Intervention (5 Days)
COMPLETED
|
5
|
5
|
|
Second Intervention (5 Days)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact Loading Effect on Bone Biomarkers in Female Runners
Baseline characteristics by cohort
| Measure |
RUN, Then RUN+J
n=6 Participants
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).
|
RUN+J, Then RUN
n=7 Participants
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).
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.3 Years
STANDARD_DEVIATION 4.2 • n=93 Participants
|
26.9 Years
STANDARD_DEVIATION 3.6 • n=4 Participants
|
26.2 Years
STANDARD_DEVIATION 3.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6Population: Only participants who completed the entire intervention period were included in the analysis.
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.
Outcome measures
| Measure |
Endurance and Jumping Exercises (RUN+J)
n=12 Participants
Participants who completed 5 days of endurance treadmill running in addition to 50 high-impact jumping exercises daily.
|
Endurance Exercise Only (RUN)
n=11 Participants
Participants who completed 5 days of endurance treadmill running daily without any additional impact exercise.
|
|---|---|---|
|
Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen
|
-3.1 ng/mL
Standard Deviation 5.7
|
1.1 ng/mL
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6Population: Only participants who completed the entire intervention period were included in the analysis.
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.
Outcome measures
| Measure |
Endurance and Jumping Exercises (RUN+J)
n=12 Participants
Participants who completed 5 days of endurance treadmill running in addition to 50 high-impact jumping exercises daily.
|
Endurance Exercise Only (RUN)
n=11 Participants
Participants who completed 5 days of endurance treadmill running daily without any additional impact exercise.
|
|---|---|---|
|
Change in Bone Remodeling Biomarker - C-terminal Telopeptide of Type 1 Collagen (CTX)
|
0.04 ng/mL
Standard Deviation 0.09
|
0.04 ng/mL
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6Population: Only participants who completed the entire intervention period were included in the analysis.
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.
Outcome measures
| Measure |
Endurance and Jumping Exercises (RUN+J)
n=12 Participants
Participants who completed 5 days of endurance treadmill running in addition to 50 high-impact jumping exercises daily.
|
Endurance Exercise Only (RUN)
n=11 Participants
Participants who completed 5 days of endurance treadmill running daily without any additional impact exercise.
|
|---|---|---|
|
Change in Blood Metabolic Marker - Parathyroid Hormone
|
3.3 pg/mL
Standard Deviation 6.1
|
-1.0 pg/mL
Standard Deviation 11.8
|
PRIMARY outcome
Timeframe: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6Population: Only participants who completed the entire intervention period were included in the analysis.
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.
Outcome measures
| Measure |
Endurance and Jumping Exercises (RUN+J)
n=12 Participants
Participants who completed 5 days of endurance treadmill running in addition to 50 high-impact jumping exercises daily.
|
Endurance Exercise Only (RUN)
n=11 Participants
Participants who completed 5 days of endurance treadmill running daily without any additional impact exercise.
|
|---|---|---|
|
Change in Blood Metabolic Marker - Insulin-like Growth Factor-1
|
-11.4 ng/mL
Standard Deviation 10.3
|
-8.0 ng/mL
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6Population: Only participants who completed the entire intervention period were included in the analysis.
Fasted serum ferritin was measured before and after each 5-day intervention period.
Outcome measures
| Measure |
Endurance and Jumping Exercises (RUN+J)
n=12 Participants
Participants who completed 5 days of endurance treadmill running in addition to 50 high-impact jumping exercises daily.
|
Endurance Exercise Only (RUN)
n=11 Participants
Participants who completed 5 days of endurance treadmill running daily without any additional impact exercise.
|
|---|---|---|
|
Change in Ferritin
|
4.1 ng/mL
Standard Deviation 11.3
|
11.4 ng/mL
Standard Deviation 11.5
|
Adverse Events
Endurance and Jumping Exercise (RUN+J)
Endurance Exercise Only (RUN)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place