CompletedNot Applicable

Impact Loading Effect on Bone Biomarkers in Female Runners

United States14 participantsStarted 2022-08-24

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen

Timeframe: 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)

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

Change in Blood Metabolic Marker - Parathyroid Hormone

Timeframe: 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

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

Trial details

NCT IDNCT05341700

SponsorVirginia Polytechnic Institute and State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-23

Results submitted2025-01-24

View on ClinicalTrials.gov More Relative Energy Deficiency in Sport trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen

Timeframe: 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)

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

Change in Blood Metabolic Marker - Parathyroid Hormone

Timeframe: 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

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