Effect of Intense Training on Ovarian Function and Bone Turnover

Sponsor
USDA, Western Human Nutrition Research Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02224976
Collaborator
University of California, Davis (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intensified Training
N/A

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

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of Intense Exercise Training on Energy Availability, Ovarian Function and Bone Turnover in Female Athletes
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intensified training

Volunteers will increase exercise training by 30% from baseline

Behavioral: Intensified Training
Volunteers will increase exercise training by 30% from baseline

Outcome Measures

Primary Outcome Measures

  1. Change in energy availability (energy intake - energy expenditure of physical activity) [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.

Secondary Outcome Measures

  1. Change in athletic performance [Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)]

    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.

  2. Change in ovarian function [Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)]

    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.

  3. Change in bone turnover markers [Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 USDA Western Human Nutrition Research Center Davis California United States 95616

Sponsors and Collaborators

  • USDA, Western Human Nutrition Research Center
  • University of California, Davis

Investigators

  • Principal Investigator: Gretchen A Casazza, PhD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT02224976
Other Study ID Numbers:
  • FL94
First Posted:
Aug 25, 2014
Last Update Posted:
Jan 28, 2016
Last Verified:
Sep 1, 2015
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by USDA, Western Human Nutrition Research Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2016