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 range18 Years – 35 Years

SexFEMALE

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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

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 range18 Years – 35 Years

SexFEMALE

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