Bone Metabolism in Premenopausal Exercising Women

Sponsor
Universidad Politecnica de Madrid
Study ID
NCT06961773
Status
Enrolling By Invitation

Conditions

  • Bone Metabolism
  • Contraception
  • Eumenorrhea
  • Low Energy Availability

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 30 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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?

Key Dates

First listed
May 8, 2025
Start date
Dec 5, 2024
Status verified
May 2025
Primary completion
Dec 20, 2025
Completion
Jun 15, 2026

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Eumhenorreic females
  • Experimental: Oral concetraceptive users

Primary Outcome Measure

Concentration of bone metabolism biomarkers [ Time Frame: immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise ]

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