AmenorrheaNCT02224976
Effect of Intense Training on Ovarian Function and Bone Turnover
A study testing Intensified Training in people with Amenorrhea, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
The investigators propose a prospective, longitudinal, department funded study protocol to evaluate whether changes in energy availability, during a period of highly intensified exercise training, will increase bone turnover markers and decrease ovarian function and exercise performance, in a dose-dependent fashion in… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amenorrhea
- What is being tested?
- Intensified Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- competitive endurance runners (racing in events ranging from 10km to ultra-marathons)
- training at least 5 days per week over the past 12 months, and more than 30 miles per week
- regular menstrual cycles (24-35 days) over the past 6 months
- maximal oxygen consumption (VO2max) > 50ml/kg/min
- English speaking
Who cannot join
- smoker
- amenorrhea
- pregnant or lactating in the past 2 years
- chronic disease that will affect bone health, metabolism or the cardiorespiratory system
- take medications that have cardiovascular or metabolic effects
- present any contra-indication to exercise testing (cardiovascular abnormalities)
- report any major illness or injury preventing training for more than 4 weeks over the past 3 months
- a history of clinical anorexia nervosa or bulimia nervosa
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Impact of Intense Exercise Training on Energy Availability, Ovarian Function and Bone Turnover in Female Athletes
The investigators propose a prospective, longitudinal, department funded study protocol to evaluate whether changes in energy availability, during a period of highly intensified exercise training, will increase bone turnover markers and decrease ovarian function and exercise performance, in a dose-dependent fashion in competitive female athletes.
Read the detailed description
Female athletes participating in sports which emphasize leanness as a factor to success, while also imposing large exercise training loads, present a high prevalence of endocrine and metabolic alterations linked to low energy stores, including suppressed ovarian function and bone loss. Increased bone turnover resulting from low energy stores and suppressed estrogen production may hold the most adverse consequences for long term health, increasing the risk of premature osteopenia, while increasing the risk of stress fractures in the short term. Chronically low energy stores may also contribute to the development of overreaching and overtraining syndromes, characterized by excessive, lasting fatigue and long-term decreases in performance, which can compromise these athletes' health and athletic career. The investigators propose the first longitudinal study aiming to demonstrate the link between low energy status, impaired ovarian function, bone turnover and decreased performance in free-living, competitive female athletes. After a 4-week baseline period of habitual training, athletes will undergo 4 weeks of intensified training (IT), during which the exercise load is increased by 30% from their individual baseline load in order to sharply increase energy expenditure. As athletes will be let to freely adjust their food intake, the investigators aim to test the hypothesis that athletes will fail to adjust food intake sufficiently to match energy expenditure, and that the resulting decrease in energy availability (EA, energy intake - energy expenditure from exercise) will influence, in a dose-dependent fashion, the suppression of estrogen production, the increase in bone turnover and the severity of performance decrement. The IT period will then be followed by a 2-week taper (REC), in which exercise training volume will be reduced by 50% from baseline. The investigators will assess whether EA returns to baseline values, and characterize changes in bone turnover during this recovery period. It is hypothesized that any improvements in exercise performance resulting from IT + REC will occur in athletes who were able to remain closest to a balanced energy state during IT. Concretely linking EA to both performance and bone health may incentivize female athletes to adopt more adequate feeding behaviors for their activity level.
- Conditions
- Amenorrhea
- Being tested
- Intensified Training
- Keywords
- exercise training
- Medical subject headings
- Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified TrainingBehavioural
Volunteers will increase exercise training by 30% from baseline
| Study group | Role | What they receive |
|---|---|---|
| Intensified training | Experimental | Volunteers will increase exercise training by 30% from baseline Receives: Behavioral: Intensified Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy availability (energy intake - energy expenditure of physical activity)
The investigators aim to capture the spectrum and variability of energy availability in endurance athletes under normal training conditions, describing in detail training regimen, total energy expenditure and nutrition habits during three distinct phases of training that are habitually followed by endurance athletes.
Measured: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Secondary outcomes (3)
Change in athletic performance
The investigators will measure the effect of energy availability on exercise performance during baseline, after 4 weeks of intensified training, and after a 2-week recovery, by measuring the relationship of energy availability to maximal oxygen consumption (VO2max) and 3200 meter time trial performance. The investigators will test the hypothesis that performance will be affected by changes in energy availability in a dose-dependent fashion.
Measured: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Change in ovarian function
The investigators will measure salivary estradiol and progesterone concentrations daily throughout the study, in order to test the hypothesis that ovarian function may be suppressed by intensified training and decreased energy availability.
Measured: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Change in bone turnover markers
The investigators will measure plasma bone turnover markers during baseline and at the end of the intensified training period, in order to test the hypothesis that bone turnover may be compromised by intensified training and decreased energy availability.
Measured: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmenorrheaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Gretchen A Casazza, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224976
- Sponsor's protocol ID
- FL94
- Status last verified
- Sep 2015
- First submitted
- 21 Aug 2014
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schaal K, VanLoan MD, Hausswirth C, Casazza GA. Decreased energy availability during training overload is associated with non-functional overreaching and suppressed ovarian function in female runners. Appl Physiol Nutr Metab. 2021 Oct;46(10):1179-1188. doi: 10.1139/apnm-2020-0880. Epub 2021 Mar 2.
PubMed 33651630
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intense Exercise Training on Energy Availability, Ovarian Function and Bone Turnover in Female Athletes
- ClinicalTrials.gov ID
- NCT02224976
- Acronym / sponsor ID
- FL94
- Conditions
- Amenorrhea
- Keywords
- exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- University of California, Davis
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Aug 2014 (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.
The investigators propose a prospective, longitudinal, department funded study protocol to evaluate whether changes in energy availability, during a period of highly intensified exercise training, will increase bone turnover markers and decrease ovarian function and exercise performance, in a dose-dependent fashion in competitive female athletes.
Detailed description
Female athletes participating in sports which emphasize leanness as a factor to success, while also imposing large exercise training loads, present a high prevalence of endocrine and metabolic alterations linked to low energy stores, including suppressed ovarian function and bone loss. Increased bone turnover resulting from low energy stores and suppressed estrogen production may hold the most adverse consequences for long term health, increasing the risk of premature osteopenia, while increasing the risk of stress fractures in the short term. Chronically low energy stores may also contribute to the development of overreaching and overtraining syndromes, characterized by excessive, lasting fatigue and long-term decreases in performance, which can compromise these athletes' health and athletic career. The investigators propose the first longitudinal study aiming to demonstrate the link between low energy status, impaired ovarian function, bone turnover and decreased performance in free-living, competitive female athletes. After a 4-week baseline period of habitual training, athletes will undergo 4 weeks of intensified training (IT), during which the exercise load is increased by 30% from their individual baseline load in order to sharply increase energy expenditure. As athletes will be let to freely adjust their food intake, the investigators aim to test the hypothesis that athletes will fail to adjust food intake sufficiently to match energy expenditure, and that the resulting decrease in energy availability (EA, energy intake - energy expenditure from exercise) will influence, in a dose-dependent fashion, the suppression of estrogen production, the increase in bone turnover and the severity of performance decrement. The IT period will then be followed by a 2-week taper (REC), in which exercise training volume will be reduced by 50% from baseline. The investigators will assess whether EA returns to baseline values, and characterize changes in bone turnover during this recovery period. It is hypothesized that any improvements in exercise performance resulting from IT + REC will occur in athletes who were able to remain closest to a balanced energy state during IT. Concretely linking EA to both performance and bone health may incentivize female athletes to adopt more adequate feeding behaviors for their activity level.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensified training | Experimental | Behavioral: Intensified TrainingVolunteers will increase exercise training by 30% from baseline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- competitive endurance runners (racing in events ranging from 10km to ultra-marathons)
- training at least 5 days per week over the past 12 months, and more than 30 miles per week
- regular menstrual cycles (24-35 days) over the past 6 months
- maximal oxygen consumption (VO2max) > 50ml/kg/min
- English speaking
Key exclusion criteria (8 listed)
- smoker
- amenorrhea
- pregnant or lactating in the past 2 years
- chronic disease that will affect bone health, metabolism or the cardiorespiratory system
- take medications that have cardiovascular or metabolic effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified TrainingVolunteers will increase exercise training by 30% from baseline | Behavioural | Intensified training |
Primary outcome
Change in energy availability (energy intake - energy expenditure of physical activity)
Time frame: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
The investigators aim to capture the spectrum and variability of energy availability in endurance athletes under normal training conditions, describing in detail training regimen, total energy expenditure and nutrition habits during three distinct phases of training that are habitually followed by endurance athletes.
3 secondary outcomes
Change in athletic performance
Time frame: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Change in ovarian function
Time frame: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Change in bone turnover markers
Time frame: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
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 28 Jan 2016.
- Derived from this study: PubMed 33651630Schaal K, VanLoan MD, Hausswirth C, Casazza GA. Decreased energy availability during training overload is associated with non-functional overreaching and suppressed ovarian function in female runners. Appl Physiol Nutr Metab. 2021 Oct;46(10):1179-1188. doi: 10.1139/apnm-2020-0880. Epub 2021 Mar 2.
- UC Davis Sports MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Gretchen A Casazza, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified Training in people with Amenorrhea, 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 5 inclusion and 8 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 28 Jan 2016. 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?
Change in energy availability (energy intake - energy expenditure of physical activity) (time frame: Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)). 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 NCT02224976, which also lists 1 linked publication.
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 28 Jan 2016.