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NCT Number: NCT03293901

Calcium Kinetic Responses to Exercise

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.

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Key information

Conditions

Nutritional Status Bones

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

United States Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

About this study

Initial military training (IMT) results in increased risk of stress fracture, particularly for females as up to 21% of females may sustain a stress fracture during IMT, an incidence that is approximately 4-fold higher than that for males. Young female adults will undergo two separate study periods in random order, one will include exercise and the other will not. Each study period will use dual stable Ca isotope methodology in order to determine Ca kinetic responses to a militarily relevant exercise, and dietary intake will be controlled. Kinetic analyses will include fractional intestinal Ca absorption (FCA), Ca flux into bone (Vo+) and out of bone (Vo-), as well as renal Ca handling. Serial blood samples collected during the study periods will also be used to determine hormonal responses to exercise. The treadmill exercise will consist of a 60 minute timed trial with load carriage (30% body weight) completed three times during the 6 day kinetic period. At the start of the study, blood will be collected for analysis of Ca and bone-related genetic markers, and habitual food intake and exercise will be assessed. The information gathered from this trial will be used to identify physiological responses that can be targeted by future interventions designed to improve bone responses to training and decrease injury risk in female Warriors.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Treadmill exercise for 60 minutes with load carriage (weighted vest, 30% body weight) completed three times during the 6 day kinetic period.

Primary outcomes

  1. Hormone response and calcium kinetics

    Time frame: 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.

    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.

Secondary outcomes

  1. Fractional calcium absorption

    Time frame: Bone measurement will be taken at baseline and FCA will be measured once during each intervention (exercise or rest) on day 0.

    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

  2. Single nucleotide polymorphisms

    Time frame: 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).

    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.

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Collaborators

  • Cornell University

Registry information

Official study title

Skeletal Hormone and Calcium Kinetic Responses to Load Carriage Exercise in Females

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2017
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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