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Calcium Kinetic Responses to Exercise

NCT ID: NCT03293901

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-16

Study Completion Date

2020-03-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nutritional Status Bones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rest

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise

Militarily relevant exercise

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

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

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cornell University

OTHER

Sponsor Role collaborator

United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Gaffney-Stomberg, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

United States Research Institute of Environmental Medicine

Locations

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United States Army Research Institute of Environmental Medicine

Natick, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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17-13-HC

Identifier Type: -

Identifier Source: org_study_id