Nutritional Status Clinical Trial
Official title:
Skeletal Hormone and Calcium Kinetic Responses to Load Carriage Exercise in Females
NCT number | NCT03293901 |
Other study ID # | 17-13-HC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 16, 2018 |
Est. completion date | March 18, 2020 |
Verified date | December 2022 |
Source | United States Army Research Institute of Environmental Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized cross-over study will identify physiological factors that underlie changes in bone metabolism that could affect skeletal injury risk, to include increases in parathyroid hormone (PTH) in response to militarily relevant exercise in females. The primary objective is to determine the hormone and calcium (Ca) response to multiple bouts of load carriage exercise in females. The investigators hypothesize that PTH will increase after multiple bouts of load carriage exercise and this increase will be due to disruption in Ca kinetics, specifically either a decrease in fractional intestinal Ca absorption (FCA) or changes in bone formation and/or resorption.
Status | Completed |
Enrollment | 21 |
Est. completion date | March 18, 2020 |
Est. primary completion date | March 18, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility | Inclusion Criteria: - Women aged 18-42 years - No current or prior military service - Exercise 2-5 x/wk - Stable body weight for 2 months (±5 lbs) - Body mass index (BMI) between 19-26 kg/m2 - VO2max between 35-50 ml·kg-1·min-1 - Willing to discontinue use of dietary supplements and abstain from alcohol for the duration of the study - Have not donated blood within the last 8 weeks Exclusion Criteria: - History of endocrine disorders (e.g., diabetes, uncontrolled thyroid dysfunction, hypoparathyroidism, or hyperparathyroidism) - History of bone-modifying disorders (e.g., osteogenesis imperfecta, osteopetrosis, or rickets) - History of cardiovascular or renal disease - Pregnancy or lactation in the last 6 months - Routine use of medications known to affect bone or calcium metabolism (e.g., thiazide diuretics, bisphosphonates, oral steroids) - A very restrictive diet or severe food allergies |
Country | Name | City | State |
---|---|---|---|
United States | United States Army Research Institute of Environmental Medicine | Natick | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
United States Army Research Institute of Environmental Medicine | Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hormone response and calcium kinetics | After dosing with dual stable calcium isotopes, changes in calcium kinetics (isotopic rations) will be measured in response to multiple bouts of a militarily relevant load carriage exercise or no exercise (rest) in females. | Exercise or rest will occur on days 0, 2, and 4 and measures will be taken daily days 0-4. After a washout period, measures will be repeated 1-4 weeks later on days 0, 2, and 4 with whichever intervention was not performed during the first study period. | |
Secondary | Fractional calcium absorption | Determine whether fractional Ca absorption (FCA) is associated with bone microarchitecture and strength in females undergoing multiple bouts of a militarily relevant load carriage exercise | Bone measurement will be taken at baseline and FCA will be measured once during each intervention (exercise or rest) on day 0. | |
Secondary | Single nucleotide polymorphisms | Evaluate whether single nucleotide polymorphisms (SNPs) previously identified to be associated with circulating 25OHD concentrations explain some of the variability in calcium kinetic responses to load carriage exercise. | SNP measurement will be taken at baseline and calcium measurements will be taken daily on days 0-4 when undergoing exercise and daily on days 0-4 when there is no exercise (rest). |
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