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Energy Availability in Female Athletes

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ClinicalTrials.gov Identifier: NCT03593382
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
Lund University
Herlev Hospital
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

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.


Condition or disease
Female Athlete Triad

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Physiological and Behavioural Aspects of Insufficient Energy Availability in Females Endurance Athletes - Impact on Metabolism, Recovery and Health
Study Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

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



Primary Outcome Measures :
  1. Energy availability [ Time Frame: Measurements performed once in the week after the two days of gynbaecological and physiological measurements ]
    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.


Secondary Outcome Measures :
  1. Resting energy metabolism [ Time Frame: Assessed once at the second visit which was between 6 weeks and 6 months after inclusion ]

    Resting metabolic rate (kcal/day and kcal/kg FFM/day by ventilated hood). RMR was assessed between 7:00 and 8:30 h, after an overnight fast, using a ventilated open hood system (Oxycon Pro 4, Jeager, Germany). The system was automatically calibrated before each test, and again weekly, by an alcohol burning test with coefficients of variability (CV) of 0.7% for O2, 1.1% for CO2, 0.8

    %for the respiratory exchange ratio, and 2% for EE. After voiding, subjects laid down for 15 min before measurements of oxygen consumption (VO2) and carbon dioxide production (VCO2) over 35 min.


  2. Work efficiancy [ Time Frame: Assessed once at the second visit which was between 6 weeks and 6 months after inclusion ]
    Work efficiency (energy metabolism during low intense exercise) (kcal/watt) efficiency was assessed by a standardized test protocol in the fasted state, initiated by the subject seated on the bicycle ergometer (Monark 939E, Monark Exercise AB, Vansbro, Sweden) for 6 min, followed by cycling for 6 min at 0W, 50W and 100W, respectively. An air-tight mask covering the mouth and nose was used in order to measure respiratory gas exchange.

  3. Substrate utilisation [ Time Frame: Substrate utilisation was assessed once at the second visit which was between 6 weeks and 6 months after inclusion ]
    Substrate utilization during and after exercise (O2 consumption and CO2 production, RQ)

  4. Bone mineral content [ Time Frame: Bone mineral content was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    Bone mineral content (g) was assessed via Dual-energy X-ray absorptiometry (DXA) (Hologic, Model Discovery 2009, Hologic Inc.,Waltham, MA, USA)

  5. Bone mineral density [ Time Frame: Bone mineral density was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    Bone mineral density (g/cm2) was assessed via Dual-energy X-ray absorptiometry (DXA) (Hologic, Model Discovery 2009, Hologic Inc.,Waltham, MA, USA)

  6. Leptin [ Time Frame: Leptin was assessed once at the first visit which was between 6 weeks and 6 months after inclusion. ]
    Leptin (ng/ml) Leptin was analyzed using Quantikine® ELISA (R&D Systems® Europe Ltd., Abingdon, UK). The lower analytic limit for leptin was 1.56 ng/mL; lower concentrations are associated with some uncertainty and therefore not automatically calculated. Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  7. Orthostatic blood pressure [ Time Frame: Orthostatic blood pressure was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    Orthostatic blood pressure (mHg) reaction after moving from supine to standing position (tilt table from 0 to 70 degree)

  8. Total cholesterols [ Time Frame: Total cholesterol was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    Total cholesterols (mmol/L) was analyzed using VITROS Chemistry Products DT slides (Ortho-Clinical Diagnostics, Buckinghamshire, UK). Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  9. HDL cholesterol [ Time Frame: HDL cholesterol was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    HDL (mmol/L) was analyzed using VITROS Chemistry Products DT slides (Ortho-Clinical Diagnostics, Buckinghamshire, UK). Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  10. LDL cholesterol [ Time Frame: LDL cholesterol was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    LDL (mmol/L) was analyzed using VITROS Chemistry Products DT slides (Ortho-Clinical Diagnostics, Buckinghamshire, UK). Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  11. Eating Disorder Inventory-3 (EDI-3) [ Time Frame: The subjects filled out the questionnaire once at the second visit which was between 6 weeks and 6 months after inclusion ]
    EDI-3 is a questionnaire assessing behavior and attitudes related to DE behavior, as well as to overt ED (12). Subjects were categorized as having DE behavior when the EDI risk subscale score for Drive for Thinness (DT) was ≥ 14, and/or a Body Dissatisfaction (BD) risk score ≥ 19, according the classification by Garner (2004) and without the presence of DSM-IV diagnosed ED.

  12. Eating disorder examination-16 (EDE-16) clinical interview score [ Time Frame: The interview was performed once at the second visit which was between 6 weeks and 6 months after inclusion ]
    The Eating Disorder Examination (EDE-16) is a validated semi-structured interview. It was used to determine whether subjects met the criteria for eating disorder, according to the DSM-IV criteria for anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified (EDNOS). All interviews were performed by the same EDE-certified member of the research team.

  13. Low Energy Availability in Females Questionnaire (LEAF-Q) score [ Time Frame: Subjects filled out the LEAF-Q once at the second visit which was between 6 weeks and 6 months after inclusion ]
    The LEAF-Q is a validated screening instrument for detecting low energy availability, assessing menstrual history, injuries and gastrointestinal function

  14. Energy intake [ Time Frame: Assessment of energy intake was performed once in the week after the two days of clinical examination ]
    Energy intake was assessed in order to calculate energy availability. Energy intake was calculated from a prospective weighed (Exido 246030 Kitchen Scale, Gothenburg, Sweden) food record, using a nutrient analysis program, Dankost 2000 (Dankost, Copenhagen, Denmark) for Danish food items, and Dietist XP (Kost och Näringsdata AB, Bromma, Sweden) for Swedish food items.

  15. Exercise energy expenditure [ Time Frame: Assessment of exercise energy expenditure was performed once in the week after the two days of examination ]
    Exercise energy expenditure was assessed in order to calculate energy availability. Heart rate monitors (Polar RS400®, Stockholm, Sweden) and training logs were used to assess exercise energy expenditure (EEE). Subjects were instructed to maintain and to follow their normal training regime. They were, furthermore, instructed to describe each session in as much detail as possible, regarding type, duration, and intensity of exercise and to wear the HR monitor at all training sessions (except swimming) and during cycling (training as well as transportation). The mean daily EEE for the sessions described as exercise by the subjects, was used and the method for calculation of current EA

  16. Estrogen (estradiol) [ Time Frame: Estradiol was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    Estradiol (pmol/L) was measured in order to assess reproductive function. Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  17. Follicle stimulating hormone (FSH) [ Time Frame: FSH was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    FSH (IU/L) was measured in order to assess reproductive function. Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  18. Luteinizing hormone (LH) [ Time Frame: LH was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    SHBG (nmol/L) was measured in order to assess reproductive function. Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  19. Prolactine [ Time Frame: Prolactine was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    Prolactine (uIU/ml) was measured in order to assess reproductive function. Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  20. Sex hormone-binding globulin (SHBG) [ Time Frame: SHBG was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    SHBG (nmol/L)

  21. Total testosterone [ Time Frame: Testosterone was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    Testosterone (nmol/L) was measured in order to assess reproductive function. Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  22. Dehydroepiandrosterone (DHEA) [ Time Frame: DHEA was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    DHEA (µmol/L) was measured in order to assess reproductive function. Blood samples were drawn following an overnight fast from an antecubital vein between 8:30 and 8:50 h, in a rested state.

  23. Training frequency [ Time Frame: The training logs were applied by the subjects for 7 days following the two examination days ]
    Training frequency was assessed using a training log filled out by each participant

  24. Training hours [ Time Frame: The training logs wereapplied by the subjects for 7 days following the two examination days ]
    Training hours were assessed using a training log filled out by each participant

  25. Reaction Time (RT) [ Time Frame: RT was assessed 3 times at the second visit which was between 6 weeks and 6 months after inclusion ]
    After 10 min of rest, the reaction time (RT [ms]) test was performed on a portable computer connected to a linear encoder (MuscleLab 4010; Ergotest Innovation, Langensund, Norway). RT was assessed by measurement of time taken to press the space bar on the keyboard when the screen changed color while the finger rested on the space bar. After three trials for familiarization, the test procedure began. Each participant performed five reaction trials. The shortest RT of the five trials was used in the statistical analysis.

  26. Knee Muscular Strentgh (KMS) [ Time Frame: KMS was assessed 3 times at the second visit which was between 6 weeks and 6 months after inclusion ]
    Directly after the RT test, knee muscular strength (KMS [Nm]) measurements were performed using isokinetic dynamometry, and each participant performed strength tests using the right leg in a consistent order.

  27. Knee Muscular Endurance (KME) [ Time Frame: KME was assessed 3 times at the second visit which was between 6 weeks and 6 months after inclusion ]
    Directly after the RT test, knee muscular endurance (KME [w]) measurements were performed using isokinetic dynamometry, and each participant performed endurance tests using the right leg in a consistent order.

  28. Non Exercise Activity Thermogenesis (NEAT) [ Time Frame: The subjects wore the accelerometers for 7 days following the two examination days ]
    To assess NEAT (kcal/day) the data analysis software ActiLife 5 (ActiGraph) was used. Subjects were instructed to wear an accelerometer on the wrist during sleep, and on the hip from getting up in the morning until bedtime, and only to take it off during showering, swimming, bicycle transportation, and training.

  29. Triglyceride [ Time Frame: Triglyceride was assessed once at the first visit which was between 6 weeks and 6 months after inclusion ]
    Triglyceride (mmol/L) was analyzed using VITROS Chemistry Products DT slides (Ortho-Clinical Diagnostics, Buckinghamshire, UK).

  30. Protein intake [ Time Frame: Assessment of protein intake was performed once in the week after the two days of clinical examination ]
    Protein intake (g/day) was assessed from a prospective weighed (Exido 246030 Kitchen Scale, Gothenburg, Sweden) food record, using a nutrient analysis program, Dankost 2000 (Dankost, Copenhagen, Denmark) for Danish food items, and Dietist XP (Kost och Näringsdata AB, Bromma, Sweden) for Swedish food items.

  31. Carbohydrate intake [ Time Frame: Assessment of carbohydrate intake was performed once in the week after the two days of clinical examination ]
    Carbohydrate intake (g/day) was assessed from a prospective weighed (Exido 246030 Kitchen Scale, Gothenburg, Sweden) food record, using a nutrient analysis program, Dankost 2000 (Dankost, Copenhagen, Denmark) for Danish food items, and Dietist XP (Kost och Näringsdata AB, Bromma, Sweden) for Swedish food items.

  32. Fat intake [ Time Frame: Assessment of fat intake was performed once in the week after the two days of clinical examination ]
    Fat intake (g/day) was assessed from a prospective weighed (Exido 246030 Kitchen Scale, Gothenburg, Sweden) food record, using a nutrient analysis program, Dankost 2000 (Dankost, Copenhagen, Denmark) for Danish food items, and Dietist XP (Kost och Näringsdata AB, Bromma, Sweden) for Swedish food items.

  33. Fiber intake [ Time Frame: Assessment of fiber intake was performed once in the week after the two days of clinical examination ]
    Fiber intake (g/day) was assessed from a prospective weighed (Exido 246030 Kitchen Scale, Gothenburg, Sweden) food record, using a nutrient analysis program, Dankost 2000 (Dankost, Copenhagen, Denmark) for Danish food items, and Dietist XP (Kost och Näringsdata AB, Bromma, Sweden) for Swedish food items.


Biospecimen Retention:   Samples With DNA
Whole Blood Serum Plasma


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • Female endurance athlete exercising at least 5 times/week

Exclusion Criteria:

  • Exclusion criteria are:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593382


Locations
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Denmark
Fertility Clinic Herlev Hospital
Herlev, Copenhagen, Denmark
Department of Human Nutrition
Copenhagen, Denmark, 1958
Sweden
Lund University
Lund, Skåne, Sweden
Sponsors and Collaborators
University of Copenhagen
Lund University
Herlev Hospital
Investigators
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Principal Investigator: Anders sjödin, Assoc prof Department of Human Nutrition, University of Copenhagen
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Responsible Party: Arne Astrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03593382    
Other Study ID Numbers: B285
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Keywords provided by Arne Astrup, University of Copenhagen:
Female endurance athletes
Energy Availability
Nutrient Availability
Bone Mineral Density
Menstrual dysfunction
Female athlete triad
Energy metabolism
Recovery after exercise
Endothelial function
Eating disorders
Performance
Additional relevant MeSH terms:
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Female Athlete Triad Syndrome
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Endocrine System Diseases
Feeding and Eating Disorders
Mental Disorders