NCT03593382

Brief Summary

The purpose of this project is to study the impact of energy availability (EA) on female endurance athletes and the adaptive consequences of insufficient EA with a special reference to the impact on energy metabolism, reproductive-, vascular- and bone health as well as exercise capacity, neuromuscular performance, ability to recover from intense exercise and the genetic interaction. Specific aims:

  • To investigate the effects of EA on energy metabolism
  • To investigate the effects of EA on reproductive, vascular- and bone health, and endocrine functions
  • To investigate the effects of EA on exercise capacity
  • To investigate the effects of EA on neuromuscular performance
  • To investigate the effects of EA on recovery after exercise
  • To identify potential dietary factors influencing EA, exercise capacity and neuromuscular performance
  • To identify potential exercise factors influencing EA, exercise capacity and neuromuscular performance
  • To identify potential psychological, behavoural and motivational aspects associated with insufficient EA The investigators hypothesize that female athletes with insufficient energy availability have attenuated energy metabolism, reduced BMD, impaired endothelial function and decreased ability to recover between exercise bouts compared to matched controls with sufficient energy and nutrient intake. The investigators also hypothesize that EA influences exercise capacity and neuromuscular performance.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

September 16, 2012

Last Update Submit

July 9, 2018

Conditions

Keywords

Female endurance athletesEnergy AvailabilityNutrient AvailabilityBone Mineral DensityMenstrual dysfunctionFemale athlete triadEnergy metabolismRecovery after exerciseEndothelial functionEating disordersPerformance

Outcome Measures

Primary Outcomes (1)

  • Energy availability

    Enenergy availability (kcal/kg FFM/day) was calculated as energy intake minus exercise energy expenditure relative to fat free mass based on the 7 day records of energy intake (kcal/day) and assessment of exercise energy expenditure (kcal/day) as well as the assessment of body composition at the first day of visit.

    Measurements performed once in the week after the two days of gynbaecological and physiological measurements

Secondary Outcomes (33)

  • Resting energy metabolism

    Assessed once at the second visit which was between 6 weeks and 6 months after inclusion

  • Work efficiancy

    Assessed once at the second visit which was between 6 weeks and 6 months after inclusion

  • Substrate utilisation

    Substrate utilisation was assessed once at the second visit which was between 6 weeks and 6 months after inclusion

  • Bone mineral content

    Bone mineral content was assessed once at the first visit which was between 6 weeks and 6 months after inclusion

  • Bone mineral density

    Bone mineral density was assessed once at the first visit which was between 6 weeks and 6 months after inclusion

  • +28 more secondary outcomes

Study Arms (1)

Female endurance athletes

Female endurance athletes recruited from Swedish and Danish national teams and competitive sport clubs

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female endurance athletes exercising minimum 5 times a week will be recruited via the Danish and Swedish National Sport Federations (Team Danmark, Danmarks Idrætsforbund and Riksidrottsförbundet) and from competivite sport clubs.

You may qualify if:

  • Female endurance athlete exercising at least 5 times/week

You may not qualify if:

  • Pregnancy
  • Metabolic disorders
  • Smoking
  • Use of psychopharmaca
  • Use of other forms of contraceptives than oral, e.g. hormonal coil or patches
  • Serious injury stopping the athlete from training ≥ 2 weeks.
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fertility Clinic Herlev Hospital

Herlev, Copenhagen, Denmark

Location

Department of Human Nutrition

Copenhagen, 1958, Denmark

Location

Lund University

Lund, Skåne County, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood Serum Plasma

MeSH Terms

Conditions

Female Athlete Triad SyndromeFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Relative Energy Deficiency in SportMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anders sjödin, Assoc prof

    Department of Human Nutrition, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2012

First Posted

July 20, 2018

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations