Impact Loading Effect on Bone Biomarkers in Female Runners

NCT05341700 | Completed Results

• 1 other identifier: 22-168
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Relative Energy Deficiency in Sport

Keywords

Bone metabolism; Endurance exercise; Low energy availability; Jump training

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Change in Ferritin

  10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6

Study Arms (2)

Endurance and Jumping Exercises

EXPERIMENTAL

5 days of endurance treadmill running and 5 sets of 10 jumping exercises

Behavioral: Impact Load Exercises

Endurance Exercise Only

ACTIVE COMPARATOR

5 days of endurance treadmill running

Behavioral: No Impact Load Exercises

Interventions

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.

Endurance and Jumping Exercises

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.

Endurance Exercise Only

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

Location

MeSH Terms

Conditions

Relative Energy Deficiency in Sport

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Enette Larson-Meyer
• Organization: Virginia Tech

enette@vt.edu

5402311025

Study Officials

• Enette Larson-Meyer, PhD

  Virginia Polytechnic Institute and State University (Virginia Tech)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized crossover study design

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 22, 2022
• Study Start: August 24, 2022
• Primary Completion: January 23, 2024
• Study Completion: April 12, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Locations

US (1)