Bone DensityNCT01059968
Low Energy Availability, Menstrual Irregularity, and Low Bone Mass
An observational study of Bone Density and Energy Availability, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
This study examines the role of energy availability on menstrual function and bone mass in female adolescent endurance athletes. Specific evaluations include dietary intake, exercise energy expenditure, training schedules, menstrual function and bone density. Read more about this study
- Who is it for?
- Ages 15 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density, Energy Availability
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: adolescent female cross country runners
Who may be able to join
- high school female cross country runners
- ages 15-17 years
- 1-5 years experience as cross country runner
- 25 miles or more/week training
Who cannot join
- medications known to affect bone metabolism
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Low Energy Availability and the H-P-A Axis, Menstrual Irregularity, and Low Bone Mass
This study examines the role of energy availability on menstrual function and bone mass in female adolescent endurance athletes. Specific evaluations include dietary intake, exercise energy expenditure, training schedules, menstrual function and bone density.
Read the detailed description
The purpose of this project is to examine the relationships among low energy availability, H-P-A axis, menstrual function and bone density and bone turnover in high school female cross country runners. Our objectives are to: 1)determine energy intake, exercise energy expenditure, and fat-free mass to examine energy availability; 2)in a subset of runners, using double labelled water, estimate total energy expenditure and indirect calorimetry to estimate resting metabolic rate; 3)assess the relationship between energy availability, hormones that regulate bone turnover, markers of bone formation and resorption and bone mineral content and density; 4)identify the relationship between energy availability, hormones that regulate menstrual function and current menstrual status; and 5)determine the energy intake and energy expenditure variables exhibiting the strongest associations with energy availability.
- Conditions
- Bone Density, Energy Availability
- Keywords
- bone density, energy availability, menstrual status, female, adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adolescent female endurance athletes | High school female cross country runners in San Diego. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Measured: 3 months
Secondary outcomes (1)
Energy availability
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- San Diego State University
- Investigators
- Marta D Van Loan, Ph.D., Study chair, USDA, ARS, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059968
- Sponsor's protocol ID
- 200816305-1
- Status last verified
- Jun 2011
- First submitted
- 28 Dec 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wood KL, Barrack MT, Gray VB, Cotter JA, Van Loan MD, Rauh MJ, McGowan R, Nichols JF. Cognitive dietary restraint score is associated with lower energy, carbohydrate, fat, and grain intake among female adolescent endurance runners. Eat Behav. 2021 Jan;40:101460. doi: 10.1016/j.eatbeh.2020.101460. Epub 2020 Nov 25.
PubMed 33307469Barrack MT, Van Loan MD, Rauh MJ, Nichols JF. Physiologic and behavioral indicators of energy deficiency in female adolescent runners with elevated bone turnover. Am J Clin Nutr. 2010 Sep;92(3):652-9. doi: 10.3945/ajcn.2009.28926. Epub 2010 Jul 7.
PubMed 20610635
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Low Energy Availability and the H-P-A Axis, Menstrual Irregularity, and Low Bone Mass
- ClinicalTrials.gov ID
- NCT01059968
- Acronym / sponsor ID
- 200816305-1
- Conditions
- Bone Density, Energy Availability
- Keywords
- bone density, energy availability, menstrual status, female, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- San Diego State University
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the role of energy availability on menstrual function and bone mass in female adolescent endurance athletes. Specific evaluations include dietary intake, exercise energy expenditure, training schedules, menstrual function and bone density.
Detailed description
The purpose of this project is to examine the relationships among low energy availability, H-P-A axis, menstrual function and bone density and bone turnover in high school female cross country runners. Our objectives are to: 1)determine energy intake, exercise energy expenditure, and fat-free mass to examine energy availability; 2)in a subset of runners, using double labelled water, estimate total energy expenditure and indirect calorimetry to estimate resting metabolic rate; 3)assess the relationship between energy availability, hormones that regulate bone turnover, markers of bone formation and resorption and bone mineral content and density; 4)identify the relationship between energy availability, hormones that regulate menstrual function and current menstrual status; and 5)determine the energy intake and energy expenditure variables exhibiting the strongest associations with energy availability.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adolescent female endurance athletes | – | –High school female cross country runners in San Diego. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- adolescent female cross country runners
Key inclusion criteria (4 listed)
- high school female cross country runners
- ages 15-17 years
- 1-5 years experience as cross country runner
- 25 miles or more/week training
Key exclusion criteria (2 listed)
- medications known to affect bone metabolism
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone density
Time frame: 3 months
1 secondary outcome
Energy availability
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Derived from this study: PubMed 33307469Wood KL, Barrack MT, Gray VB, Cotter JA, Van Loan MD, Rauh MJ, McGowan R, Nichols JF. Cognitive dietary restraint score is associated with lower energy, carbohydrate, fat, and grain intake among female adolescent endurance runners. Eat Behav. 2021 Jan;40:101460. doi: 10.1016/j.eatbeh.2020.101460. Epub 2020 Nov 25.
- Derived from this study: PubMed 20610635Barrack MT, Van Loan MD, Rauh MJ, Nichols JF. Physiologic and behavioral indicators of energy deficiency in female adolescent runners with elevated bone turnover. Am J Clin Nutr. 2010 Sep;92(3):652-9. doi: 10.3945/ajcn.2009.28926. Epub 2010 Jul 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta D Van Loan, Ph.D. study chair
USDA, ARS, Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Density and Energy Availability, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059968, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.