Набор по приглашению NCT06961773

Bone Metabolism in Premenopausal Exercising Women

Без фазы С лечением Contraception Bone Metabolism Low Energy Availability Eumenorrhea

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Low energy availability, High energy availability.
Кому может быть актуально: Состояния в реестре: Contraception, Bone Metabolism, Low Energy Availability, Eumenorrhea. Базовые параметры: 18 лет — 30 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

Другое 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.
Другое 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.

Первичные конечные точки

Concentration of bone metabolism biomarkers [Срок оценки: immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise]
Concentrations of other biochemical biomarkers [Срок оценки: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise]
Concentrations of sex hormones [Срок оценки: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise]
Bone mineral density [Срок оценки: At the screening phase]

Вторичные конечные точки (3)

Training status variables [Срок оценки: At the screening phase]
Body composition variables [Срок оценки: Immediately pre- and post-nutritional intervention (bioimpedance) and DXA at the screening]
Body metrics [Срок оценки: Measured at the screening phase]

Критерии участия

Критерии включения

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.