Relative Energy Deficiency in Sport Clinical Trial
Official title:
The Effect of Impact Loading on Bone Biomarkers in Energy-Restricted Female Runners
NCT number | NCT05341700 |
Other study ID # | 22-168 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 24, 2022 |
Est. completion date | April 12, 2024 |
Verified date | May 2024 |
Source | Virginia Polytechnic Institute and State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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, eumenorrheic 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.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 12, 2024 |
Est. primary completion date | January 23, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Females runners with regular menstrual cycles, not using contraceptives - Body Mass Index between 18.5-25.0 kg/m2 - Weight stable (+/- 2 kg) for 6 months - Running volume of =30 miles per week, frequency of at least 5 days per week - VO2max of =45 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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Polytechnic Institute and State University | Blacksburg | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Polytechnic Institute and State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Bone Remodeling Biomarker - N-terminal propeptide of type 1 procollagen | Levels of N-terminal propeptide of type 1 procollagen will be measured from fasted blood samples drawn before and after each 5-day intervention. The radioimmunoassays (RIA) will be performed on all samples once the study is completed. | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 | |
Primary | Change in Bone Remodeling Biomarker - C-terminal telopeptide of type 1 collagen | Levels of C-terminal telopeptide of type 1 collagen will be measured from fasted blood samples drawn before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) will be performed on all samples once the study is completed. | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 | |
Primary | Change in Blood Metabolic Marker - Parathyroid hormone | Levels of parathyroid hormone will be measured from fasted blood samples drawn before and after each 5-day intervention. These blood samples will be sent out to a local lab service at each timepoint. | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 | |
Primary | Change in Blood Metabolic Marker - Insulin-like Growth Factor-1 | Levels of insulin-like growth factor-1 collagen will be measured from fasted blood samples drawn before and after each 5-day intervention. The ELISAs will be performed on all samples once the study is completed. | 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 | |
Primary | Change in 24-hour Glucose Patterns | Blood glucose levels will be measured every 15 minutes during each 5-day intervention period using a continuous glucose monitor sensor secured to the arm. The results will provide a descriptive profile of daily glucose patterns while participants are in an energy-restricted state and exercising, either only running on a treadmill daily or running on a treadmill and completing 5 sets of 10 jumping exercises daily. | Continuous collection for 5 consecutive days during each intervention | |
Secondary | Change in Running Economy | Running economy will be measured by collecting and analyzing inspired and expired air continuously during 3 4-minute progressive stages while running on a treadmill. The last two minutes of oxygen consumption and carbon dioxide production data will be used to determine metabolic economy (ml oxygen consumed per kg body weight per minute relative to the set work performed). Running economy will be evaluated in the laboratory at baseline and on the 5th day of each intervention period, three tests total. | 12-minute measurement in laboratory | |
Secondary | Change in Body Weight | Body weight will be measured on a digital scale to the closest 0.1 kg. Body weight will be measured the day before, each of the 5 days during, and the day after each intervention. | 1-minute measurement in laboratory |
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