Virginia Polytechnic Institute and State University
Who can join
Adults 18 to 35, female only, with Relative Energy Deficiency in Sport. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 ProcollagenPrimary· 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.
Group
Value
95% CI
Endurance and Jumping Exercises (RUN+J)
-3.1
± 5.7
Endurance Exercise Only (RUN)
1.1
± 7.2
Change in Bone Remodeling Biomarker - C-terminal Telopeptide of Type 1 Collagen (CTX)Primary· 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.
Group
Value
95% CI
Endurance and Jumping Exercises (RUN+J)
0.04
± 0.09
Endurance Exercise Only (RUN)
0.04
± 0.12
Change in Blood Metabolic Marker - Parathyroid HormonePrimary· 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.
Group
Value
95% CI
Endurance and Jumping Exercises (RUN+J)
3.3
± 6.1
Endurance Exercise Only (RUN)
-1.0
± 11.8
Change in Blood Metabolic Marker - Insulin-like Growth Factor-1Primary· 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.
Group
Value
95% CI
Endurance and Jumping Exercises (RUN+J)
-11.4
± 10.3
Endurance Exercise Only (RUN)
-8.0
± 6.3
Change in FerritinSecondary· 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Fasted serum ferritin was measured before and after each 5-day intervention period.
Group
Value
95% CI
Endurance and Jumping Exercises (RUN+J)
4.1
± 11.3
Endurance Exercise Only (RUN)
11.4
± 11.5
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Virginia Polytechnic Institute and State University
Last refreshed: 19 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05341700.