NCT06961773

Bone Metabolism in Premenopausal Exercising Women

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Universidad Politecnica de Madrid · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Contraception
• Bone Metabolism
• Low Energy Availability
• Eumenorrhea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-05
• Primary completion: 2025-12-20
• Completion: 2026-06-15
• First posted: 2025-05-08
• Last updated: 2025-05-08

Locations

1 site across 1 country: Spain