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Enrolling by invitation NCT06961773

Bone Metabolism in Premenopausal Exercising Women

No phase Interventional Contraception Bone Metabolism Low Energy Availability Eumenorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low energy availability, High energy availability.
Who it may be relevant to
Registry conditions: Contraception, Bone Metabolism, Low Energy Availability, Eumenorrhea. Basic parameters: 18 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Bone Metabolism in Exercising WOMEN: Influence of Low Energy Availability and Sex Hormone Fluctuations

Overview

The main goal of this study is to examine how sex hormones and low energy availability affect the concentrations of bone remodelling markers at rest and after a running protocol. The research questions to be addressed are: 1: Does the ovarian hormone profile influence serum bone marker concentrations in women exercising resting and in response to to exercise? 2\. Are there differences in response to low energy availability in bone marker concentrations between eumenorrhoeic female athletes and oral contraceptive users? 3: Is the response of bone markers affected by different exercise stimuli: endurance or aerobic endurance? 4: Do bone markers return to baseline levels after 24 hours of high energy availability diet after 6 days of low energy availability?

Detailed description

To achieve the aim of the study, there will be two experimental groups - e.g. eumenorrhoeic females and oral contraceptive users - who, after screening, will be randomly assigned to a low- or high-energy diet. After 6 days on this diet, the participant will undergo an intervallic running protocol and blood samples will be taken before and after the test. The following month the participant will do the other type of diet.

Interventions

  • Other Low energy availability
    Participants follow 6 days of a low-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass.
  • Other High energy availability
    Participants follow 6 days of a high-energy availability diet. The kilocalories of each diet are prescribed individually based on their fat-free mass.

Primary outcome measures

  • Concentration of bone metabolism biomarkers [Time frame: immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise]
  • Concentrations of other biochemical biomarkers [Time frame: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise]
  • Concentrations of sex hormones [Time frame: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise]
  • Bone mineral density [Time frame: At the screening phase]
Secondary outcome measures (3)
  • Training status variables [Time frame: At the screening phase]
  • Body composition variables [Time frame: Immediately pre- and post-nutritional intervention (bioimpedance) and DXA at the screening]
  • Body metrics [Time frame: Measured at the screening phase]

Eligibility criteria

Inclusion criteria

  • Be healthy and between 18 and 30 years old.
  • Engage in endurance sports that involve running (such as athletics, running, triathlon, trail running, etc.) for 3 to 12 hours per week..
  • Eumenorrheic females with regular menstruation at least 6 months prior to the study.
  • Monophasic oral contraceptive users at least 6 months prior to the study.

Exclusion criteria

  • Amenorrheic females.
  • Pregnant females.
  • Affected by any disorder related to the hypothalamo-pituitary-ovarian axis.
  • Having suffered a bone fracture in the year before the study.
  • Taking any medication or supplements that affect bone metabolism.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

Spain · 1 center
  • Faculty of physical activity and sport sciences — Madrid

Identifiers

NCT: NCT06961773 · 2023-091

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗