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Effect of Intense Training on Ovarian Function and Bone Turnover

Primary Purpose

Amenorrhea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensified Training
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Amenorrhea focused on measuring exercise training

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • USDA Western Human Nutrition Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensified training

Arm Description

Volunteers will increase exercise training by 30% from baseline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 21, 2014
Last Updated
January 26, 2016
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02224976
Brief Title
Effect of Intense Training on Ovarian Function and Bone Turnover
Official Title
Impact of Intense Exercise Training on Energy Availability, Ovarian Function and Bone Turnover in Female Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amenorrhea
Keywords
exercise training

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensified training
Arm Type
Experimental
Arm Description
Volunteers will increase exercise training by 30% from baseline
Intervention Type
Behavioral
Intervention Name(s)
Intensified Training
Intervention Description
Volunteers will increase exercise training by 30% from baseline
Primary Outcome Measure Information:
Title
Change in energy availability (energy intake - energy expenditure of physical activity)
Description
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.
Time Frame
Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Secondary Outcome Measure Information:
Title
Change in athletic performance
Description
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.
Time Frame
Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Title
Change in ovarian function
Description
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.
Time Frame
Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)
Title
Change in bone turnover markers
Description
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.
Time Frame
Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen A Casazza, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33651630
Citation
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.
Results Reference
derived
Links:
URL
http://www.ars.usda.gov/Main/docs.htm?docid=11240
Description
USDA Western Human Nutrition Research Center
URL
http://www.ucdmc.ucdavis.edu/sportsmedicine
Description
UC Davis Sports Medicine

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Effect of Intense Training on Ovarian Function and Bone Turnover

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