- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00572871
Hormonal and Bone Turnover Marker Response to an Acute Bout of Resistance or Plyometric Exercise
September 30, 2016 updated by: University of Missouri-Columbia
We are interested in determining if there exist a short-term response in the serum markers and hormones that participate in the regulation of bone tissue formation and breakdown to a single, high-intensity exercise session of weight lifting (resistance exercise) or jumping (plyometrics).
We are also interested in determining if the bone marker response to exercise is altered by changing the negative energy state caused by the exercise treatment, when subjects are given a moderate calorie meal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bone tissue responds to impact and strain forces, like high-intensity exercise, by upregulating the bone remolding process, resulting in the deposition of calcium phosphate minerals into the collagen matrix of bone.
Bone remodeling is a continually active process that involves both activation cells regulating bone formation (osteoblasts) and resorption (osteoclasts).
Alterations in the balance between formation and resorption are critical for changes in bone density and mineral content to occur, which is regulated by several hormones including vitamin D and growth hormone, the sex hormones estrogen and testosterone, and parathyroid hormone.
Importantly, it remains unclear how single bouts of physical activity contribute to the overall changes in remodeling and whether those acute alterations can be detected in the hours after exercise.
Additionally, research studies examining the effects of exercise on bone remodeling often draw blood samples after 24 hours of physical inactivity, potentially diminishing the magnitude of the exercise response.
Therefore, we plan to evaluate the acute effects of plyometrics and resistance exercise on changes in serum hormones and markers of bone turnover in non-sedentary, healthy males, with or without a moderate calorie supplement.
Study Type
Observational
Enrollment (Actual)
12
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Male participants apparently healthy and non-sedentary free of disease that affects bone and not have used or currently use any medication that affects bone.
Description
Inclusion Criteria:
- Male
- No symptoms of disease
- Non-sedentary
- Age 25-65
Exclusion Criteria:
- Medications or supplements that affect bone metabolism or prevent exercise
- Previous or current medical condition affecting bone health, including osteoporosis.
- Cardiovascular disease
- Metallic implants affecting accuracy of bone density scan
- Current smoker
- Current participation in high-intensity jumping or resistance exercise in the last 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Exercise after fasting
Will complete 2 resistance exercise sessions and 2 plyometric exercise sessions after a 10-hour fast
|
single bout of resistance exercise
|
|
No exercise
Will complete a ten-hour fast but do no exercise
|
Will not do any exercise
|
|
Exercise after snack
Will complete 2 resistance exercise sessions and 2 plyometric exercise sessions 2 hours following a 500 calorie nutritional supplement
|
single bout of plyometric exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
serum bone turnover markers
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
serum hormones regulating bone turnover
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pamela S Hinton, Ph.D., University of Missouri-Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
December 12, 2007
First Submitted That Met QC Criteria
December 12, 2007
First Posted (Estimate)
December 13, 2007
Study Record Updates
Last Update Posted (Estimate)
October 4, 2016
Last Update Submitted That Met QC Criteria
September 30, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1097239
- 65438 (Other Identifier: University of Missouri)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.